No device-related warning letters were released by the US FDA the week of 26 January.

Under an extensive COVID-19 plan and executive order signed on 21 January, the US president explained how he’ll beef up testing and manufacturing of medtech to fight the virus.

The largest medical device lobby group in the US says it’s open to the administration’s decision to invoke the Defense Production Act to boost testing and PPE production, but wants to be consulted on how to implement it.

The US agency has announced another month of webinars aimed at labs and manufacturers that are (or have) developed diagnostic tests for the novel coronavirus.

Tom McLain tells how the new MCIT policy from the US Medicare agency – and winning support from Congress – will guarantee Medicare coverage for his company’s product, an artificial intelligence-enabled in vitro diagnostic platform.

The document from the Medical Device Innovation Consortium aggregates external data sources, various statistical methods and lays out other considerations for sponsors to help speed up and bolster a premarket product application to the US FDA.

The updates reflect changes to standards on medical electrical equipment and a wide range of device types.

The UK responsible person is the UK equivalent of the Authorized Representative in the EU. MedTech Europe’s Jesús Rueda gives an update on the early experiences of medtech manufacturers seeking to comply with the UK’s new standalone regulations.

The European Commission has reluctantly allowed virtual audits in the context of new MDR and IVDR. The EU notified body association is helping the collective effort to meet its strict requirements.

In this week’s podcast, Medtech Insight's managing editor Marion Webb and deputy editor Reed Miller discuss highlights from the recent J.P. Morgan Healthcare and North American Neuromodulation Society (NANS) virtual meetings. And London-based reporter Barnaby Pickering profiles start-up CorWave SA, which developed a left ventricular assist device for treating end-stage heart failure.

The sentences are the latest chapter in a long-running off-label marketing case.

Thermo Fisher Scientific has agreed to buy Mesa Biotech for $450m in cash and Hillrom will acquire Bardy Diagnostics for $375m in cash. Both deals will add complementary digital health solutions, which may be a continued trend in 2021.

Medicare now covers transcatheter edge-to-edge repair for both functional and degenerative mitral regurgitation under specific conditions.

A top executive at the Swedish company spoke with Medtech Insight about how the mobility and data reliability of 5G cellular technology will change how medtech manufacturers design their products.

DJO Global will buy Trilliant Surgical to further its ongoing expansion into the US foot and ankle market.

In this week’s podcast, Medtech Insight's managing editor Marion Webb and deputy editor Reed Miller discuss highlights from the recent J.P. Morgan Healthcare and North American Neuromodulation Society (NANS) virtual meetings. And London-based reporter Barnaby Pickering profiles start-up CorWave SA, which developed a left ventricular assist device for treating end-stage heart failure.

The document from the Medical Device Innovation Consortium aggregates external data sources, various statistical methods and lays out other considerations for sponsors to help speed up and bolster a premarket product application to the US FDA.

Medicare now covers transcatheter edge-to-edge repair for both functional and degenerative mitral regurgitation under specific conditions.

DePuy Synthes expects its Velys robotic-assisted system to be cost-effective, easy-to-use and to be well-suited for use in ambulatory surgery centers.

SENZA PDN showed Nevro's HF10 spinal cord stimulation therapy provided sustained relief to patients with painful diabetic neuropathy. Results of a separate trial showed HF10 improved outcomes in patients with non-surgical refractory back pain.

Delfi Diagnostics will use the new funds to expand its team of cancer researchers and machine-learning experts to validate its novel approach for early cancer detection through multiple prospective clinical trials.