After a 30-year career of working mainly for UK-based EU notified bodies, Sue Spencer is changing tack and moving into a consultancy role. Here, she talks openly about how the ongoing regulatory changes in the EU are creating a very different environment for those working at notified bodies.

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.

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.

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.

OncoCyte Corp. welcomed new clinical operations and marketing VPs; immuno-sequencing diagnostics firm Adaptive Biotechnologies elected two new directors; and more.

At this year's American Diabetes Association meeting in San Francisco, Medtech Insight sat down with Hiten Chawla, Medtronic's VP of global marketing for its diabetes business, to learn more about their announcements and plans. See what Chawla said about it here.

At this year's American Diabetes Association (ADA) meeting in San Francisco, medtech giant Medtronic made several key announcements including a collaboration with Tidepool Loop, the start of a new patient trial to develop its next-generation hybrid closed-loop system and another trial to improve its sensor technology. Medtech Insight met up with Hiten Chawla, Medtronic's VP of global marketing for its diabetes business, to learn more about these plans.

Varian is expanding its cancer care solutions portfolio with two new acquisitions in the interventional oncology space. The medtech giant said it will pay $185m to buy Endocare Systems, based in Austin, Texas; and Alicon, based in Hangzhou, China.

GT Medical Technologies' co-founder and CTO, David Brachman, presented clinical results showing the company's GammaTile device may prevent the return of a brain tumor in patients who underwent resection surgery after recurring brain tumors. See what Brachman said about it here.

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.

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.