Blog Tag: Medical Device

FDA Approves Medtronic Melody TPV For Implantation in Failed Pulmonary Heart Valves

Medtronic recently announced that its Melody® Transcatheter Pulmonary Valve (TPV) is the first transcatheter pulmonary valve to receive FDA approval for implantation in patients with failed surgical bioprosthetic pulmonary

Certain Medical Devices Exempted from 510(k) Requirements

The Food and Drug Administration (FDA) recently identified a list of Class II Medical Devices that, when finalized, will be exempt from premarket notification (510(k)) requirements.  This publication was made by the FDA pursuant

FDA Approval for Medtronic’s Reveal LINQ ICM with TruRhythm Detection

On March 13, 2017, Medtronic announced FDA 510(k) clearance for its Reveal LINQ Insertable Cardiac Monitor (ICM) with TruRhythm Detection.

Previously, Medtronic received Ministry of Health, Labor and Welfare approval for the device 

Ingestible e-Pill Approved For Use in Hospitals

Ingestible e-Pill Approved For Use in Hospitals

BodyCap, a France-based company said to be dedicated to the development of miniature wireless electronic sensors, recently announced that its e-Celsius® device has earned CE mark approval and is now commercially available for hospital

Positive Clinical Results for Using Myriad’s BRACAnalysis CDx® for Identifying Breast Cancer Patients for Treatment with Lynaparza

Myriad Genetics recently announced clinical results showing that its BRACAnalysis CDx® test was able to identify patients with HER2-negative metastatic breast cancer who had improved response with Lynparza (olaparib), AstraZeneca’s

Obamacare Replacement Would Repeal Medical Device Tax

Republican lawmakers recently proposed a replacement of Obamacare known as the American Health Care Act (AHCA).  One provision of the proposed legislation would permanently repeal Obamacare’s 2.3% medical device excise tax

Voxello Receives FDA 510(k) Clearance for the Noddle Communication Device

Voxello recently announced FDA 510(k) clearance of its noddle™ device, following submission of its application in October 2016.  According to the press release, the noddle gives patients who are unable to speak a way to communicate

Outsourcing of Services in the Medical Device Industry

As the medical device market continues to grow, the medical device industry has strived to reduce costs through outsourcing. An industry report has found that the global medical device outsourcing market was valued at $33.2 billion in 2016,

EU Finalizes Medical Device Regulations

EU Finalizes Medical Device Regulations

The European Council has released the final versions of its Medical Device Regulations (MDR) and In Vitro Diagnostics Regulations (IVDR).  According to JDSupra, the Council of the European Union will vote on March 7, 2017 whether to adopt

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Ethicon To Acquire Torax Medical, Inc.

Ethicon Inc. announced on February 17 that it reached an agreement to acquire Torax Medical, Inc.  According to its website, Torax Medical is a privately held medical device company developing a minimally invasive surgical treatment

Smith & Nephew, Arthrex Settled Suture Anchor Patent Dispute Before Trial

On February 14, 2017, U.S. District Judge Michael Mosman of the United States District Court, District of Oregon granted a Joint Stipulated Motion for Dismissal with Prejudice submitted by Plaintiffs Smith & Nephew, Inc. and John

Potential Repeal of Medical Device Tax

With the upcoming Republican-dominated Presidency and Congress in 2017, the Affordable Care Act, or at least parts of it, look to be on the chopping block.  One of the changes that may be forthcoming is a repeal of the 2.3% medical device

FDA Announces International Draft Guidance for Clinical Evaluation of Software as a Medical Device

The U.S. Food and Drug Administration announced the availability of a draft guidance for the clinical evaluation of software as a medical device (SaMD).  The draft guidance was prepared by the SaMD Working Group of the International

MHRA Updates Guidance on Healthcare Apps as Medical Devices

MHRA Updates Guidance on Healthcare Apps as Medical Devices

Healthcare apps are becoming a greater part of everyday life.  The increasing prominence and functionality of these apps has lead to the question of when healthcare apps should be regulated as medical devices.  In the United States,

Medical Device Investor Forum – Oct. 27-28 in Irvine, CA

Medical Device Investor Forum – Oct. 27-28 in Irvine, CA

OCTANe, an Orange County-based non-profit life sciences and technology accelerator organization, has announced the agenda for its 11th Annual Medical Device & Investor Forum (MDIF), which will be held on October 27-28, 2016, in

Johnson and Johnson Insulin Pump Potentially Vulnerable to Cyber Attack

Johnson and Johnson Insulin Pump Potentially Vulnerable to Cyber Attack

Johnson & Johnson recently warned its customers of a cybcersecurity issue with one of its insulin pumps, potentially leaving thousands of users vulnerable.  According to Johnson & Johnson’s letter, “a cybersecurity

FDA Planning Board Emphasizes Use of Data Sharing in Medical Device Monitoring

The FDA‘s planned National Evaluation System for Health Technology (NEST) will focus on new forms of clinical data, data sharing, and advanced analytics as the keys to optimizing the medical device ecosystem, says 

FDA Reaches Agreement with Industry for Reauthorization of Medical Device User Fees

The Food and Drug Administration has issued a statement announcing that the FDA and representatives from the medical device industry and laboratory community have reached an agreement in principle on proposed recommendations for the fourth

Increase in Funding to Med Device Startups

Despite a drop in the second quarter of 2016, medical device funding is expected to finish stronger this year than in 2015.  CB Insights has released a report on the funding and deal activity within the medical device industry since

FDA Issues Proposed Guidance for Changes to Medical Device Software

FDA Issues Proposed Guidance for Changes to Medical Device Software

The U.S. Food & Drug Administration (FDA) issued a proposed guidance on August 8, 2016, regarding software changes to medical devices.  The proposed guidance relates to requirements for submitting medical device software