In the only device-related warning letter released by the US FDA this week, a maker of Baker Jejunostomy tubes and intestinal tubes used for bowel decompression was cited for quality systems violations.

CMS has completed its new national Medicare Coverage with Evidence Development policy for transcatheter aortic valve replacement. The final decision memo largely maintains the recommendations from the draft version released in March, including more flexible criteria for centers establishing TAVR programs, while emphasizing the importance of the interdisciplinary heart team for decision-making about valve replacement.

The US FDA officially shuttered its Alternative Summary Reporting (ASR) Program on 21 June and released to the public millions of adverse event reports received by the agency between 1999 and 2019. See what the agency's device center chief, Jeff Shuren, said about it here.

A two-day US FDA advisory committee meeting this week yielded plenty of discussion about the apparent mortality risk tied to paclitaxel-coated balloons and stents, but few definitive conclusions.

The US FDA today formally shuttered its Alternative Summary Reporting (ASR) Program and released to the public millions of adverse event reports received by the agency between 1999 and 2019. The FDA also wants to make its Manufacturer and User Device Experience (MAUDE) database – where all adverse events are stored – easier to use.

A former Democratic congressional staffer has joined the medtech industry lobby group to shepherd efforts including the medical device tax repeal, upcoming device user-fee negotiations, and more.

In the only device-related warning letter released by the US FDA this week, a maker of Baker Jejunostomy tubes and intestinal tubes used for bowel decompression was cited for quality systems violations.

The US FDA today formally shuttered its Alternative Summary Reporting (ASR) Program and released to the public millions of adverse event reports received by the agency between 1999 and 2019. The FDA also wants to make its Manufacturer and User Device Experience (MAUDE) database – where all adverse events are stored – easier to use.

Intertwining design changes and document control is vital for manufacturers – especially for those whose creeping changes to a medical device can turn it into an altogether different product that requires a new 510(k) or PMA from the US FDA. Longtime agency investigator Laureen Geniusz weighs in on what she has seen in the field and offers other nuggets of design change advice.

Abbvie is taking on Allergan's aesthetics portfolio as part of its $63bn takeover deal. The acquisition includes Allergan's CoolSculpt body contouring system and a new FDA-approved device for muscle strengthening.

Early cancer detection firm Grail Inc. fills CEO position internally. Head of care solutions moves up to CEO post at Roche Diagnostics and Smiths Medical brings on a new CEO.

Bert van Meurs, chief business leader of Philips' image-guided therapy business, recently spoke with Medtech Insight about two new product launches to add to the Azurion angiographic platform and the new partnership with Microsoft's HoloLens 2 mixed realty technology, among other new developments. See what van Meurs said about it here.

In this edition of Device Week, Medtech Insight's Catherine Longworth chats with Marion Webb about her upcoming Market Intelligence story based on interviews with the biggest players in the diabetes market at the recent annual American Diabetes Association meeting. And Reed Miller discusses Global Kinetics' recent data on its Personal KinetiGraph that can help identify Parkinson's patients most likely to benefit from device-assisted therapy and Myriad Genetics' POLO trial results.

Just months after receiving USA FDA approval for its SuperSaturated Oxygen (SSO₂) Therapy for heart-attack treatment, Californian company TherOx has been acquired by Zoll Medical for an undisclosed sum.

A Texas man’s lawsuit against the hospital that implanted him with a recalled Medtronic spinal device can move toward trial, the Texas State Court of Appeals for the 12^th District has ruled. See what Justice Greg Neeley wrote in the court's opinion.

A snapshot of global medical device approvals captured during the past week in Medtech Insight's Approvals Tracker. The week of 18-24 June was very slow for approvals, with no new PMAs, panel-track PMA supplements, or de novos.

In this edition of Device Week, Medtech Insight's Catherine Longworth chats with Marion Webb about her upcoming Market Intelligence story based on interviews with the biggest players in the diabetes market at the recent annual American Diabetes Association meeting. And Reed Miller discusses Global Kinetics' recent data on its Personal KinetiGraph that can help identify Parkinson's patients most likely to benefit from device-assisted therapy and Myriad Genetics' POLO trial results.

A new study shows that Global Kinetics' Personal KinetiGraph (PKG) wearable sensor system can identify the best candidates for device-assisted therapies for Parkinson's disease including deep brain stimulation. See what Fatta Nahab, a neurologist at the University of California, San Diego, said about it here.

A new study shows the Personal KinetiGraph wearable monitor can help clinicians identify the Parkinson’s disease patients most likely to benefit from device-assisted therapies, including deep brain stimulation.

A snapshot of global medical device approvals captured during the past week in Medtech Insight's Approvals Tracker, including a PMA supplement for Agilent’s PD-L1 IHC 22C3 pharmDx companion diagnostic for Merck’s Keytruda (pembrolizumab), an anti-PD-1 drug, for patients with head and neck squamous cell carcinoma. The US FDA also approved a supplement for the Cochlear Nucleus Profile Plus Series Cochlear Implant, designed to be safe with magnetic resonance imaging.

The results of the POLO trial, showing a benefit of Myriad’s BRACAnalysis CDx companion diagnostic for AstraZeneca’s Lynparza (olaparib) to treat pancreatic cancer offer more support for the new guidelines from the National Comprehensive Cancer Network recommending genetic testing for all pancreatic cancer patients. Myriad also stands to benefit from the growing support for genetic testing of breast cancer patients.