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.

Passage of a US FDA diagnostics reform bill is one priority for the US House Energy and Commerce Committee in 2019, said cosponsor and committee member Rep. Diana Degette, D-Colo.

Cost-recovery requirements have induced regulator Swissmedic to introduce notification fees for lower-risk, class I devices, IVDs and products that use non-viable human tissues, with immediate effect.

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.

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

The International Organization for Standardization (ISO) has strengthened benefit-risk language in the latest redo of ISO 14971, the voluntary standard that instructs device-makers on how to best put together a risk management program. Regulators – including US FDA – are increasingly considering benefit-risk when weighing product availability and regulatory compliance issues. And Jos Van Vroonhoven, convener of a joint working group that revised the standard, says a more global regulatory emphasis on risk management and a desire to clarify the document in general led ISO to revise the standard. Also: Van Vroonhoven identifies four updated clauses in the revamped standard that firms should keep a sharp eye on.

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.

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.

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.

The new CEO of Smith & Nephew, Namal Nawana, sat down with Medtech Insight during the JP Morgan Healthcare Conference to discuss his plans for putting the British medical giant on track for growth. See what he had to say here about the company's M&A strategy.

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.

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.