Device industry trade group AdvaMed has issued a revised version of its broadly used Code of Ethics. The new document, set to take effect on Jan. 1, 2020, discusses how device firms can work with health-care professionals to deliver high-quality, innovative care, without violating ethical principles or anti-bribery laws. See what AdvaMed's Matt Wetzel said about it here.

In a statement to the Medicare Payment Advisory Commission, the medtech industry group bemoans the lack of consideration for medical device alternatives to opioids in treating pain management. The group says the commission should factor in such alternative treatments, per the SUPPORT Act, in their recommendations to Congress in March.

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

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.

Will there be enough resources for IVD manufacturers to be audited in time against the EU's IVD Regulation? A survey from TEAM-NB reveals a drop in notified body numbers just at a time when more resources are needed.

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.

Speaking the language of both devices and drugs is an important step sometimes missed by makers of combination products. Being "bilingual" is especially important during a facility inspection by US FDA, Johnson & Johnson's Susan Neadle says.

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

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.

On this week's podcast, Medtech Insight's Catherine Longworth chats with Marion Webb about some key takeaways from this year's JP Morgan Healthcare Conference. That includes a Q&A with Smith & Nephew's new CEO Namal Nawana on his growth strategy for the British medtech giant, new partnership announcements between medtech and tech companies, and trends in digital health.

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.

Proteus Digital Health announced a new partnership with Fairview Health Services and the University of Minnesota Health to prescribe capecitabine, a common chemotherapy drug, encapsulated with a sensor to colorectal cancer patients. Under the program, patients are prescribed the "digital capecitabine" and will be monitored remotely to see when they take their meds and for other health data. The goal is to improve patients' treatment adherence and improve outcomes.

The planned $10bn medical device tender in Turkey, closely watched by multinational and local companies alike, has been postponed, again, until April 16. Local Turkish device companies are objecting strongly to the government’s approach to the tender, arguing that it is adding more pressure on local industry as it is already under serious financial distress.

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

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.

It was another record year for novel device approvals by US FDA, driven by the big uptick in de novo classifications for low-to-moderate-risk devices in 2018. Meanwhile, original PMA approvals dropped significantly. An analysis and infographic on FDA device approval trends in 2018.

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.