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Set Alert for Approvals

Minute Insight: Maestro Cues The Music With CE Mark For Moon Surgical

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.

Minute Insights Robotic Surgery

News We’re Watching: ICD Trial Success, EOFlow Restraining Order, Hamilton Ventilator Recall

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.  

Commercial Clinical Trials

Cardio Catch-Up: Advisory Panel Gives Recor Momentum Toward US Launch Of RDN System

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.

Advisory Committees Clinical Trials

Cardio Catch-Up: Medtronic Still Has Work To Do On RDN After FDA Advisory Panel

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.

Advisory Committees Approvals

Withings' Smart Scale Passes US FDA Test; Clearance For Detecting Atrial Fibrillation

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

Approvals FDA

News We’re Watching: Califf Talks ORA Reorg, Contaminants Bring Ventilator Recall, 27-Year Sentence On Medicare Fraud

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.  

Regulation Approvals

Regulatory And Commercial Should Be 'Hand In Hand' For Dx Success, Expert Says

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.

Clinical Trials Regulation

Analyst Expects Roche’s Newly FDA-Cleared Insulin Patch Pump Will Have ‘Limited Impact’

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.

Research & Development Commercial

More But Slower Medtech Approvals

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

FDA Regulation

News We’re Watching: ReCor And Medtronic Head To RND Panel, Clearances For Anika And Sequel, ZimVie And Brainlab Partner

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. 

Approvals Advisory Committees

GE HealthCare Wins FDA Nod For Wireless Monitoring Solution

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

Patient Monitoring Approvals

Stanford Study Highlights Need For Transitional Reimbursement Pathway

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.

Approvals Regulation

News We’re Watching: Boston Scientific's POLARx Is Approved, IABP Recalls, Intricon Opens Facility in Costa Rica

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.

Recalls Approvals

News We’re Watching: Medtronic Kickbacks Case, BARDA Contract For Cue, Imeka Neuroimaging Software Cleared

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.

Legal Issues Enforcement

Orthopedics Corner: Catalyst Looks To Clinical Data To Distinguish Its Shoulder Arthroplasty Technology

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.

Clinical Trials Orthopedics
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