Approvals

The Paris-based start-up has picked up a CE mark for the latest generation of its Maestro system, a tool designed to make laparoscopic surgery easier and safer.

This week, Medtronic presented data from two new real-world trials confirming that ICDs save lives; a restraining order was issued against EOFlow in Insulet’s intellectual property case; and Polarean’s MRI gas XENOVIEW received a new Medicare reimbursement code.  

The majority of FDA’s circulatory systems devices panel agreed that ReCor’s Paradise ultrasound renal denervation system offers a safe and effective therapy for patients with hypertension. The panel’s endorsement means ReCor will likely be the first company to reach the US market with an RDN system.

FDA’s circulatory system advisory panel narrowly voted against Medtronic’s Symplicity Spyral, because one of the pivotal trials of the radiofrequency renal denervation system missed its primary endpoint and the patient population evaluated in the trial does not match the requested indication.

Withings receives FDA clearance for first body weight scale to detect atrial fibrillation.

This week, FDA Commissioner Robert Califf described plans for restructuring the Office of Regulatory Affairs; Studies found chatbots don’t give trustworthy advice to cancer patients; and the owner of an Atlanta genetic testing lab was sentenced to 27 years in prison over a massive Medicare fraud scheme.  

Considering where and how a test will be used, and what kind of evidence regulators will want before clearing it, is key for developers of at home and point-of-care diagnostics.

Roche received FDA clearance for its Solo insulin patch pump, but is expected to face significant barriers to entry in the highly competitive US insulin pump market.

If the pace is maintained in the second half of the year, 2023 could see the most US device approvals in a decade.

This week, the US FDA geared up for a renal denervation panel meeting; a microbiology panel meeting was announced; and a hyaluronic acid patch to promote rotator cuff healing, a novel spiral tampon, and a tibial neuromodulation device to treat incontinence all won FDA clearance. 

GE HealthCare’s newly FDA-cleared Portrait Mobile enables real-time continuous wireless monitoring of patient vital signs such as respiration rate.

Results of a study of FDA and CMS data found that 44% of 64 new devices were granted some kind of Medicare coverage within 5 years of FDA approval of clearance.

This week, FDA cleared Terumo's Reveos automated whole blood processing system, Abbott adds the Alinity-h hematology system to its comprehensive lab diagnostics lineup, Movano moves forward with "smart ring" technology, and more.

This week, a court ordered a Medtronic whistleblower to hand over records of his media contacts; Cue Health was awarded $28m to develop a multi-disease respiratory panel; and the FDA granted a zero fluoroscopy Indication to some Biosense Webster cardiac ablation devices.

Orthopedics Corner is a new series highlighting new developments in spine and orthopedics technology you may have missed. Catalyst OrthoScience CEO Carl O’Connell, along with surgeon and researcher Matthew Budge, talked to Medtech Insight about Catalyst’s innovation in shoulder arthroplasty.