No device-related warning letters were released by US FDA the week of Jan. 22.

There had been warnings that the first notified bodies would not be designated by the European Commission until late July 2019, 10 months before the full application of the EU Medical Device Regulation. But now that BSI is the first notified body in the EU to be designated under the MDR, are things looking up?

Diagnostics regulatory reform is on the agenda of the US House Energy and Commerce Committee this year. See what Rep. Diana DeGette, D-Colo., a senior member of the committee, who helped introduce the 'Verifying Accurate Leading-edge IVCT Development Act' (VALID Act), a proposed diagnostics reform bill, had to say about device safety here.

AdvaMed has revised its industry Code of Ethics. The revised code, which will come into effect in 2020, includes new sections on off-label communications and training health-care professionals to use new medical technology.

The number of direct-to-consumer advertisements for molecular-based tests rose exponentially from 1997 to 2016, according to a medical marketing analysis released earlier this month in the Journal of the American Medical Association. Simultaneously, laboratory test manufacturers increased spending on ads and direct spending on physicians who work with the tests from $75.4m to $82.6m.

A new regulation in China legalizes overseas inspections of device- and drug-makers, making risk-based audits routine tasks.

Having the right subject matter experts on hand day or night is critical to acing a US FDA facility inspection, Eli Lilly's David Shore advises. In fact, to be sure it always has the right experts available to answer investigator questions, the firm has restructured its organization to include two new roles to support audits: global product stewards and global process stewards.

AdvaMed has revised its industry Code of Ethics. The revised code, which will come into effect in 2020, includes new sections on off-label communications and training health-care professionals to use new medical technology.

A new regulation in China legalizes overseas inspections of device- and drug-makers, making risk-based audits routine tasks.

Derived from Strategic Transactions, Informa's premium source for tracking life-sciences deals, the bimonthly Pacts In Medtech feature highlights notable technology alliances, R&D partnerships and commercial collaborations. This edition covers industry pacts that were sealed in November and December 2018.

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. 14 -19, 2019.

Proteus Digital Health announced a new partnership with Minneapolis-based Fairview Health Services and the University of Minnesota Health to prescribe "digital capecitabine," encapsulating the common chemotherapy drug with Proteus' sensor, to colorectal cancer patients. The goal is to achieve medication adherence, leading to enhanced treatment and outcomes, through home-based monitoring. See what George Savage, Proteus' co-founder and chief medical officer, had to say about the new digital oncology program here.

Edwards Lifesciences and Boston Scientific announced this week that the firms had resolved an ongoing global patent dispute.

Abbott has exercised an option to buy Cephea Valve Technologies, developer of a minimally-invasive replacement heart valve, for an undisclosed sum.

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.

The new alliance is focused on developing a "digital therapeutic" for the treatment of depression. They hope it will take its place as an effective option among current drug and other cognitive therapies.

The list of medical device approvals outside the US captured by Medtech Insight's Approvals Tracker in 2018 was shorter than in 2017, but it includes approvals from 14 different territories – more than one-fifth of the approvals came from emerging markets – covering more than 50 different indication categories.

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.