Showing all posts written by Joy Wang
Nestlé Health Science S.A., a subsidiary of Nestlé S.A., is the owner of more than a dozen nutritional supplement brands. It has previously invested in several businesses that develop solutions for nutrition- and digestion-related disorders and diseases.
Phagenesis is the developer of the Phagenyx®, a device designed for the treatment of dysphagia, the inability to safely swallow. Phagenesis explains that the device aims to restore neurological control of swallowing lost due to stroke by delivering Pharyngeal Electrical Stimulation (PES). According to Phagenesis, electrical stimulation of the pharynx induces a new part of the brain to assume control of such lost swallowing function.
The Phagenyx® product includes a treatment catheter and a base station. The catheter carries two electrodes, which deliver the PES, and is designed to be introduced through the nose. The catheter can optionally accommodate a feeding tube. The catheter is connected to the base station, which controls the amount of stimulation delivered and stores the patient’s treatment information. Phagenyx® is currently undergoing clinical evaluation. While the device received its CE mark in 2012, it has yet to be approved for use in the US by the FDA.
According to its press release, Nestlé Health Science’s acquisition of Phagenesis will start with an upfront payment followed by milestone-based payments contingent upon successful completion of Phagenyx’s® European and US development programs.
The acquisition was announced on the same day former Fresenius Medical Care CEO Ulf Mark Schneider joined Nestlé S.A. In June 2016, Nestlé announced Mr. Schneider’s appointment to the position of CEO, which will become effective on January 1, 2017.
Representatives Mike Fitzpatrick (R-PA) and Louise Slaughter (D-NY) announced plans to propose the Medical Device Guardians Act of 2016. According to a press release from Rep. Fitzpatrick, the Act is “a package of bills aimed at strengthening the FDA medical device review process and increasing accountability for dangerous products.”
If passed, the Act will require doctors to report medical device-related deaths and serious injuries to the FDA. Under current rules, only medical device manufacturers, importers, and certain user facilities are required to report medical device-related deaths and serious injuries to the FDA. User facilities are currently defined as “a hospital, an ambulatory surgical facility, a nursing home, and outpatient treatment facility, or an outpatient diagnostic facility which is not a physician’s office.” The proposed Act will extend the existing reporting requirements to include “a physician or physician’s office.”
The Act is the most recent effort by Rep. Fitzpatrick to reform the FDA medical device review and approval process. Reps. Fitzpatrick and Slaughter have pointed to recent controversies related to implantable sterilization devices and power morcellators used in laparoscopic surgery as motivation for introducing the Act. Last year, Reps. Fitzpatrick and Slaughter were part of a group of twelve members of Congress who requested the U.S. Government Accountability Office to investigate the events leading to the FDA’s black box warning against the use of power morcellators in November 2014. Black box warnings are the strongest warnings by the FDA and call attention to serious or life threatening risks.
Hanover, New Hampshire – Researchers at Dartmouth’s Department of Computer Science has unveiled “Wanda,” a prototype “magic wand” that securely transmits information to a medical device.
According to the paper authored by Timothy J. Pierson, Xiaohui Liang, Ronald Peterson, and David Kotz, Wanda is designed configure a target device to connect to a local Wi-Fi network and to other devices on the network. Wanda can also configure the target device to send data to a particular location in the cloud.
The paper states that Wanda consists of a wand that attaches via USB to a Wi-Fi access point and a protocol installed in the target device. To securely transmit network or other information, the user simply detaches the wand from the Wi-Fi access point and touches the wand to the target device. In lab testing, researchers transmitted network information to a blood pressure monitor by touching the wand to the monitor. Using the transmitted information, the monitor automatically connected to the local Wi-Fi network and uploaded information to a simulated Electronic Health Record.
The wand communicating with a blood pressure monitor. Credit: Dartmouth College
The paper states that the wand contains two antennae that detect radio signals from the target device and discerns the target device from potentially unsecure devices based on distance from the wand. After detecting the target device, the wand imparts its saved information onto the device.
Wanda was developed as part of the Trustworthy Health and Wellness (THaW) project. THaW aims to “provid[e] trustworthy information systems for health and wellness.” THaW is funded by the NSF’s Secure and Trustworthy Cyberspace Program. The Dartmouth researchers are scheduled to present their findings in April at IEEE INFOCOM 2016 in San Francisco, California.
The FDA recently announced establishment of the Patient Engagement Advisory Committee (PEAC). According to a notice published by the FDA, the PEAC will advise the Commissioner of the FDA, presently Dr. Stephen Ostroff, M.D., “on complex issues relating to medical devices, regulation of devices, and their use by patients.” In an FDA Voice blog post, Nina L. Hunter, Ph.D., and Robert M. Califf, M.D., stated:
[The PEAC] will give FDA the opportunity to obtain expertise on various patient-related topics, with the goal of improving communication of benefits and risks and increasing integration of patient perspectives into the regulatory process.
According to the FDA, PEAC will have 9 core voting members, including a committee chair, to be selected by the Commissioner. The voting members, who will have expertise in patient needs in connection with medical care, clinical research, and healthcare communication, will serve overlapping terms of up to 4 years. The notice states that the Commissioner may also select a technically qualified voting consumer representative recommended by consumer oriented organizations. Depending on the meeting topic, a pool of nonvoting industry representatives selected by the Commissioner and nominated by the medical device industry may also participate in PEAC meetings.
The FDA has established a public docket for comments on topics the PEAC could consider, which currently include: “[FDA] guidance and policies, clinical trial or registry design, patient preference study design, benefit-risk determinations, device labeling, unmet clinical needs, available alternatives, patient reported outcomes and device-related quality of life or health status issues, and other patient-related topics.” The public is invited to provide comments online, or by mail to: Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Comments must reference Docket No. FDA-2015-N-3166, and must be received by the FDA by November 20, 2015.
The FDA is also soliciting nominations for voting members, which must be received by November 20, 2015, the voting consumer representative, which must be received by October 21, 2015, and a pool of nonvoting industry representatives, which must be received by October 21, 2015.
CE certification allows for free movement of the Hourglass™ device within the EU and indicates that the Hourglass™ device meets EU safety, health, and environmental requirements and complies with EU legislation. According to EU guidelines, Class IIb includes “[a]ll non-invasive devices intended for modifying the biological or chemical composition of blood, other body liquids, or other liquids intended for infusion into the body . . . .”
The press release suggests that the Hourglass™ device is the first device of its kind – George Wallace, CEO of EMBA Medical Limited, stated:
This is the first integrated, over-the-wire device designed for peripheral embolization procedures . . . . The goal with over-the-wire design is to provide physicians with accurate, stent-like delivery of the device in the vessel. We believe that the Hourglass™ implant will provide a level of confidence, precision, and control for peripheral embolization procedures that physicians have come to enjoy over the years while performing other types of over-the-wire endovascular procedures.
In addition, EMBA Medical recently received ISO certification for its facility in Miramar, Florida, where the Hourglass™ devices will be manufactured. Specifically, EMBA Medical received certification for ISO 13485:2003 for quality management systems specific to organizations providing medical devices.
The Hourglass ™ device is not presently approved for sale in the United States.
Amid myriad media reports about potential vulnerabilities in medical device cybersecurity and the FDA’s efforts to strengthen medical device cybersecurity, the IEEE Cybersecurity Initiative released a report entitled “Building Code for Medical Device Software Security.” The report sets forth a set of elements aimed at reducing the vulnerability of medical device software to malicious attackers. The report employs a loose definition of “medical devices,” ranging from wearable devices to electronic health record systems.
The report highlights the most common types of software vulnerabilities that are exploited by malicious attackers. The bulk of the report proposes standards for five software implementation considerations in ways to (1) avoid, detect, or remove specific vulnerabilities like using memory-safe languages, secure coding standards, and automated thread safety analysis; (2) ensure proper cryptography; (3) improve software integrity; (4) impede attacker analysis or exploitation; and (5) detect malicious attacks. The report further brings up four software design considerations about maintaining service during or restore service after an attack and supporting privacy requirements, but does not propose any standards. Finally, the report notes that the “building code” itself should be consistent in categorizing particular types of attacks and should be maintained over time.
The IEEE Center for Secure Design has also released “Avoiding the Top 10 Software Security Design Flaws,” to give advice on ways to address particular issues including data authentication, authorization, and validation; cryptography; sensitive data classification; and integrating external software components.
The FDA recently issued a draft guidance document regarding its policy of accepting scientifically valid clinical data from foreign clinical studies in support of premarket submissions for medical devices. In view of the “increasingly global” nature of clinical research, the FDA issued the guidelines to clarify the standards under which foreign clinical data will be accepted.
Under the FDA’s existing framework, and in particular for Premarket Approvals (PMA), the FDA will accept foreign clinical data if it conforms with the 1983 version of the Declaration of Helsinki, or the local rules of the country in which the clinical study was conducted. If using the local rules, the sponsor must detail any differences between the local rules and the Declaration, and explain why the local rules are more protective of human test subjects. One of the proposed rules would require that foreign clinical studies used to support PMAs, Investigational Device Exemptions (IDEs), Humanitarian Device Exemptions (HDEs), and 510(k)s be conducted according to good clinical practice (GCP).
The FDA also states that, for many device premarket applications, like 510(k)s, PMAs, and de novos, foreign clinical data “can be used to support clearance or approval of the application” as long as the data constitutes valid scientific evidence under 21 CFR 860.7. The FDA encourages sponsors to submit the foreign clinical studies for review through the FDA’s Pre-Submission process, before using the studies to support an application.
The draft guidance document further lists three special considerations that may be applied to foreign clinical studies to ensure that they satisfy FDA standards, namely (1) differences in clinical conditions, (2) differences in study populations, and (3) differences in regulatory requirements. These special considerations are intended to identify whether the results of a foreign clinical study can be generalized to apply to US clinical practices, the US population, and FDA requirements, respectively. To illustrate application of these special considerations, the FDA has provided 7 examples and explains the outcome of applying the special considerations to the examples.
According to the Federal Register, public comments on the draft guidance document must be submitted to the FDA by July 20, 2015. Comments may be submitted online to Regulations.gov, or mailed to Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
(March 2, 2015) Johnson & Johnson announced that Cardinal Health has made a binding offer to acquire Cordis, a Johnson & Johnson company, for $1.99 billion. The press release indicates that the sale price includes $1.944 billion in cash and $46 million in net receivables. According to Cardinal Health’s announcement regarding the acquisition, it expects the deal to close by the end of 2015. Highlights of the deal can be found here.
According to its website, Cordis manufactures cardiovascular and endovascular products, for example stents, catheters, guidewires, and vena cava filters. According to news articles, Cordis was acquired by Johnson & Johnson in 1996 for about $1.8 billion.
According to its website, Cardinal Health is a health care services company that distributes pharmaceuticals and medical products to healthcare providers and pharmacies. Cardinal Health also manufactures various medical products. Last year, Cardinal Health acquired AccessClosure for $320 million.
Congressman Erik Paulsen (R., Minn.) and Senator Orrin Hatch (R., Utah) recently introduced bills H.R. 160 and S.149, respectively. Both bills are part of an effort to repeal the 2.3% excise tax on medical device manufacturers and importers imposed by the Affordable Care Act, commonly known as ObamaCare. Guidance from the IRS on the medical device excise tax can be found here.
Where previous attempts to modify or repeal the medical device excise tax have stalled in the Senate, the Washington Times reports that prospects of the repeal passing both houses of Congress are bolstered by the newly Republican-controlled Senate. Further, as is reflected on Congress.gov, both bills have significant bipartisan support, and, according to The Hill, efforts to gain more supporters are ongoing.
But, The Hill reports that Republican and Democrat supporters of the repeal disagree on how to offset the revenue that would be lost should the tax be repealed. Further tempering optimism for repeal of the excise tax is a January 9, 2015 report from the nonpartisan Congressional Research Service, entitled “The Medical Device Excise Tax: Economic Analysis,” which states in its summary that the effect of the tax on the medical device industry will be minor because of the relatively inelastic demand for medical services, the small tax rate, and the numerous exemptions from the tax. Contrary to industry reports on the tax that predict significant adverse effects on innovation and employment, the Congressional Research Service’s report suggests that “most of the tax will fall on consumer prices, and not on profits of medical device companies.”
H.R. 160 has been referred to the House Ways and Means Committee while S.149 has been referred to the Senate Finance Committee. Check back here for further developments on efforts to repeal the medical device excise tax.
The Nokia Sensing XCHALLENGE has announced its Q3 2014 Winners. According to XPRIZE, a non-profit organization that manages public competitions to advance technological development, the Nokia Sensing XCHALLENGE was offered to accelerate the availability of portable and affordable devices capable of accurately collecting real-time health information. The Nokia Sensing XCHALLENGE consisted of two distinct competitions: the first was held in Q1 2013 and the second was held in Q3 2014. The organization states that, through the Nokia Sensing XCHALLENGE competition, it seeks to accelerate the development of continuous monitoring technologies that track the health of the user, particularly for use in developing countries that lack access to affordable, fast, and reliable diagnostic tests. The competition guidelines focused on whether the entries (1) were relevant to public health needs; (2) advanced sensing technology in a unique and creative way; (3) accurately, reliably, and effectively collected and reported data; (4) were multi-functional and easily integrated with other technologies; and (5) were simple and easy to use for the end user.
XPRIZE recently announced that the Q3 2014 Grand Prize Winner was DNA Medicine Institute (DMI), Inc. of Cambridge, Massachusetts, led by CEO Dr. Eugene Chan. The company received an award of $525,000. DMI’s winning devices, including the rHealth X and X1 models (below middle and right) are intended for the ordinary consumer to diagnose various diseases from a single drop of blood. According to DMI, the devices operate by scanning proprietary diagnostic nanostrips for fluorescence and wirelessly collecting vital signs in real time using an array of sensors that adhere to a subject’s body (the devices can also send the collected data to mobile devices). According to USPTO records, DMI is the assignee of several pending patent applications generally directed towards: Multicoded Analytical Nanostrips; Microfluidic Passive Mixing Chip; Flow Based Clinical Analysis; and Capillary Manipulation of Clinical Samples. DMI is also a finalist for the $10M Qualcomm Tricorder XPRIZE, another competition managed by XPRIZE that seeks to stimulate innovation in the field of consumer diagnostic devices.
The Nokia Sensing XCHALLENGE also announced five additional Distinguished Award Winners that received an award of $120,000, including:
Biovotion of Zurich, Switzerland, led by CEO Dr. Andreas Caduff, created the Vital Sign Monitoring platform, a wearable armband that collects and analyzes data about various physiological parameters and sends the information to the user’s mobile device.
Eigen Lifescience of Stanford, California, led by Dr. Shan Wang, created the Eigen Diagnostic Platform, a device that uses magnetic field sensors to analyze interchangeable diagnostic cartridges to diagnose various diseases from a drop of blood. The information can be transmitted to the user’s doctor using an accompanying mobile device application.
Endotronix Wireless Health Monitoring of Woodbridge, Illinois, led by CEO Dr. Harry Rowland, created a device that monitors heart disease by measuring pulmonary artery pressure using a sensor implanted into the pulmonary artery. An accompanying device wirelessly retrieves pressure data from the sensor and uploads the data to a secure cloud server.