Blog Tag: Medical Device

Popular Social Media Platforms in the Pharma Industry

Social Media Success: Trends in Pharma Digital Strategies

According to data published by business intelligence firm Cutting Edge Information, the majority (73%) of pharmaceutical marketing teams expect to use or continue to use the popular social media forum Facebook to facilitate their digital

Digital Currencies and Blockchain in the Medical Arena

Recently, digital currencies, such as bitcoin, have greatly increased in popularity. Some of this popularity may be attributed to digital currencies’ many purported advantages over traditional currencies, such as that blockchain

EIT Acquires Patent Portfolio For 3D Printed Spinal Fusion Cages

EIT Acquires Patent Portfolio For 3D Printed Spinal Fusion Cages

On August 22, 2017, Emerging Implant Technologies GmbH (EIT) announced the acquisition of 22 patents and pending applications relating to 3D printed expandable spinal fusion cages based on living hinges from Dr. Morgan Lorio, a spinal surgeon

Pediatric Healthcare Innovators Compete for Funding

Pediatric Healthcare Innovators Compete for Funding

The FDA, according to its website, currently supports eight consortia that provide advice and funding to help commercialize technologies for pediatric care.  The FDA defines “pediatric” as encompassing devices used

Teleflex Acquires UroLift® Maker NeoTract for $1.1 Billion

Teleflex Acquires UroLift® Maker NeoTract for $1.1 Billion

Wayne, Pennsylvania-based Teleflex Inc.  announced it will purchase privately-held NeoTract Inc. for approximately $1.1 billion. According to the press release, Teleflex will pay NeoTract $725 million when the deal closes and

Nanochip Device with Potential To Heal Tissue and Organs

According to a regenerative medicine article published online on August 07, 2017 in the journal Nature Nanotechnology titled “Topical tissue nano-transfection mediates non-viral stroma reprogramming and rescue”, Researchers

The Medical Device Tax Lives On

For opponents of the 2.3 percent medical device tax, it looked like the repeal/replacement of the Affordable Care Act would alleviate their concerns.  However, following the failure of repeal legislation that would have killed off,

K2M Obtains Exclusive License to Patent Portfolio

K2M Group Holdings, Inc. recently announced its acquisition of a portfolio of 17 issued and pending patents for expandable interbody technology.  According to K2M, the company is a global leader in the medical device industry and provides

Excelsius GPSTM: Globus Medical Receives 510(k) Clearance for Robotic Surgery Platform

Excelsius GPSTM: Globus Medical Receives 510(k) Clearance for Robotic Surgery Platform

Globus Medical announced early today that the Excelsius GPSTM surgical platform has received 510(k) clearance from the U.S. Food and Drug Administration (FDA), as reported by a press release dated August 17, 2017.

Globus Medical, which

House Passes Bill Relaxing Reporting Requirements

The U.S. House of Representatives recently passed the FDA Reauthorization Act of 2017.  This bill seeks to change the requirement for companies to report medical device malfunctions to the FDA.  Previously, companies had to submit a report

Trump Administration Policy Statement Calls for FDA Premarketing Activities to be Funded Entirely by Industry Fees

The Trump White House released a Statement of Administration Policy on Wednesday in response to the House of Representatives’ passage of H.R. 2430, a bill that would reauthorize the use of four FDA user fee programs: the Prescription Drug

Philips Acquires EGI

Philips recently announced that it will purchase Electrical Geodesics, Inc. (EGI).  The total value of the deal is estimated to be GBP 29.0 million (approximately $36.9 million).  According to its website, EGI designs, develops, and

Medtronic’s Recent Interactions with the FDA

It has been a busy couple of months between Medtronic and the Food and Drug Administration (FDA), with Medtronic experiencing both recalls and approvals from the government agency.  Below is a brief summary of some recent of Medtronic’s

FDA Approves Bayer’s myBETAapp™

On May 30, 2017, Bayer announced FDA approval of a supplemental Biologics License Application for Bayer’s myBETAapp™ and BETACONNECT Navigator™.  The myBETAapp joins the growing field of medical mobile applications,

ECRI Institute Releases Guidance on How to Protect Your Medical Device Systems

The ECRI Institute released new guidance in its article: “Ransomware Attacks: How to Protect Your Medical Device Systems” on May 18, 2017.  The report recommends various protective actions for hospitals to take and points to critical

Philips Buys RespirTech for Undisclosed Amount

Philips Buys RespirTech for Undisclosed Amount

Dutch conglomerate Philips recently announced that it will purchase Respiratory Technologies Inc. (RespirTech). According to its website, RespirTech describes itself as a St. Paul, Minnesota-based provider of inCourage vests, which

FDA Approves “First-of-its-kind” Infant Medical Device

FDA Approves “First-of-its-kind” Infant Medical Device

The U.S. Food and Drug Administration (FDA) recently authorized the use of what it described as a “first-of-its-kind” medical device to treat infants for a birth defect called esophageal atresia, in which the upper esophagus

Confirm Rx: Abbott Receives CE Mark for Smartphone Compatible ICM

Confirm Rx: Abbott Receives CE Mark for Smartphone Compatible ICM

Abbott recently announced the CE Mark and first use of what it claims is “the world’s first smartphone compatible” insertable cardiac monitor (ICM), as reported by a press release dated May 8, 2017.

According to the press release,

WannaCry Malware and Medical Device Security

The WannaCry virus has infected and frozen computers in many industries around the world.  According to a news source report, the virus has extorted doctors and hospital administrators for the keys to unlock and regain access to their

Boston Scientific Announces Worldwide EMBLEM™ Study

Boston Scientific recently announced that it is launching a worldwide study for its EMBLEM™ MRI Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) device.  According to the press release, a multicenter trail of the device