US FDA is taking a cautious approach to rolling out the test phase of its pre-certification program for digital health products to keep it within legal limits. See what Bradley Merrill Thompson, an attorney at Epstein Becker & Green, had to say about the limited scope of the current plan here.

No device-related warning letters were released by US FDA the week of Jan. 15.

In setting his agenda for the US Senate Finance Committee in 2019, incoming Chairman Chuck Grassley, R-Iowa, says he will continue to cosponsor bills to end the device tax, focus on lowering prescription drugs and other medical product health-care costs, expand tax breaks for business, and make sure Congress has a strong hand in negotiating trade and tariff talks.

A law firm has filed a class action suit against the US Department of Health and Human Services trying to force broader Medicare reimbursement of continuous glucose monitors. Currently, federal health programs will only cover specific types and uses of the diabetes treatment technology.

Notified body and medtech industry trade associations both issued formal statements pointing out that delays in designating notified bodies are the biggest barrier to products being able to comply with the new EU Medical Device Regulation before deadlines. Time is running out.

Device companies in Canada and foreign firms selling to the market likely will be able to adjust to Health Canada’s stepped-up device safety “action plan,” but small health-care facilities and some clinics may face challenges in adjusting to new reporting rules, says the agency and Canadian device industry group MEDEC.

When ISO TR 24971 – a Technical Report that offers device-makers guidance on international risk management standard ISO 14971 – was first published in 2013, not many people knew it existed. But now that the TR is being updated in tandem with ISO 14971, it's a must-have document that includes valuable instruction related to a host of risk-related issues. In particular, TR 24971:20XX includes informative new annexes that tackle device cybersecurity and how firms should handle risk management for products designed before ISO 14971 existed.

Here's a table cross-referencing the current 2007 version of international risk management standard ISO 14971 and its revised draft version, which will likely be published by the International Organization for Standardization (ISO) later this year.

The International Medical Devices Database from the International Consortium of Investigative Journalists – an output of ICIJ's recent string of "Implant Files" stories that were critical of industry – offers information on more than 700,000 device recalls, field safety notices and safety alerts documented in 11 countries. While device-makers and shrewd consumers will discover a bevy of useful data in the public repository, it could prove confusing for laypeople. A recalls expert and an ex-FDA official weigh in.

Prenatal testing firm Natera appoints a new chief operating officer and interventional cardiovascular device firm Shockwave Medical seats a new board chairman, among recent medtech and biotech personnel moves.

This edition of Medtech Money Flow rounds up the M&A and venture financing deals, as recorded in our M&A and VC Deal Trackers, from Jan. 7-13, 2019.

About eight months into his role as CEO of Smith & Nephew, Namal Nawana has revamped the firm's leadership team and created strategic imperatives to put the British medical device giant on the growth track. Medtech Insight sat down with Nawana at this year's JP Morgan Healthcare Conference in San Francisco to learn more about his plans for growing Smith & Nephew.

This week, a new president at otolaryngology device firm Beltone, plus a chief business officer comes on board at immune and oncology imaging company ImaginAb. And Ra Medical Systems, maker of laser-based therapy devices, welcomes a chief commercial officer.

GE Healthcare is making a bid to become the leader in precision medicine by collaborating with Vanderbilt University Medical Center to develop AI-powered diagnostic tools for cancer care.

Ascensia Diabetes Care plans to start selling its first continuous glucose monitoring devices this year based on a distribution deal with Zhejiang POCTech Co. Ltd, announced Jan. 7 at the JP Morgan Healthcare Conference. The partnership will also include product development.

This week's edition of Medtech Insight's Results Recap, the weekly roundup of major device trial-results from Meddevicetracker.com, includes just one entry as the 2019 is off to a slow start for trial results announcements. Pulse Biosciences announced encouraging results from the clinical efficacy study of its Nano-Pulse Stimulation technology to treat patients with sebaceous hyperplasia.

US FDA has granted a de novo clearance to Bruin Biometrics’ SEM Scanner, which is the first device cleared to assess parts of a patient’s body that may be at risk for pressure ulcers.

A snapshot of global medical device and diagnostics approvals recorded during the past week in Medtech Insight's Approvals Tracker. Terumo and Cook each nabbed US FDA approvals for endovascular devices.

Starts & Stops compiles all the clinical trial announcements, initiations, completions and suspensions tracked by Meddevicetracker. This edition covers trial announcements from Dec. 30 to Jan. 7, including announcements from Abbott, Roche, Insightec, and Terumo.

Starts & Stops compiles all the clinical trial announcements, initiations, completions and suspensions tracked by Meddevicetracker. This edition covers trial announcements from Dec. 24-30, so there is just one entry this week - Vectorious' announcement of the first-in-human trial of the V-LAP left-atrial monitor.

A snapshot of global medical device approvals captured during the past two weeks by Medtech Insight's Approvals Tracker. Among the noteworthy approvals in the closing days of 2018, Roche/Foundation Medicine captured Japanese approval for its comprehensive companion diagnostic.