Surgeons are opting for alternate hysterectomy methods since the FDA warned power morcellation may spread cancerous cells through the body.

The agency allows IVD developers to use assays with different instrument systems without submitting a new 510(k), as long as they meet certain safety and efficacy criteria.

The US FDA has finally established a new regulatory category for hearing aids that will allow Americans with mild to moderate hearing loss to purchase the devices directly over the counter without a prescription or prior exam.

NICE’s recently launched early value assessment (EVA) pilot has hit a milestone this month, with AliveCor’s KardiaMobile 6L the first product to be given the go-ahead for NHS use in England under the scheme.

The spotlight is on IVDs in the post-COVID phase. Innovators in university spin-outs and the established industry have responded with new technologies, creating a vibrant scene. Regulators and reimbursors must not disrupt the momentum, say BIVDA’s regulatory affairs manager Ashleigh Batchen and chief executive Doris-Ann Williams.

A  proposed budget from the US Senate appropriations committee would fund the FDA's device activities at $663m for fiscal 2023, marking a modest increase from 2022 but a drop from House and administration requests. 

The US FDA has received more reports of adverse outcomes, including deaths, from the breakdown of foam in many sleep apnea devices from Philips.

The EU must keep its medtech regulation under review as rapidly changing technology and external market factors may be challenging the operability of some aspects of the new medtech regulations, especially for less mature businesses and SMEs. Legal medtech expert, Shuna Mason, of CMS explains why.

Latest information from the European Commission suggest that future notified bodies designated under the MDR, and even the IVDR, may not be in a position to issue certificates until March 2023.

The US FDA has received more reports of adverse outcomes, including deaths, from the breakdown of foam in many sleep apnea devices from Philips.

The US FDA has finally established a new regulatory category for hearing aids that will allow Americans with mild to moderate hearing loss to purchase the devices directly over the counter without a prescription or prior exam.

De Oro Devices’ plans to add more indications for its portable device for freezing gait associated with Parkinson’s disease. In 2023, the company hopes to address , multiple sclerosis, stroke and cerebral palsy, and add mobility-gait software.

SyncThink recently obtained a CE mark for the Eye-Sync system, using the PicoXR Neo 3 Pro Eye virtual-reality headset, to measure and quantify eye-movement biomarkers reflective of neurological impairment or disease.

MedRhythms’ digital therapeutics platform aims to improve walking and functional outcomes in patients with multiple sclerosis, Parkinsons’ disease and chronic stroke. With around $32m in funding to date, the start-up boasts collaborations with major medical centers and a partnership with Biogen.

According to reports from Caixin and Bloomberg, TikTok’s Chinese owner ByteDance paid about $1.5bn for Amcare Healthcare, the operator of women’s and children’s hospitals in major Chinese cities.

SyncThink recently obtained a CE mark for the Eye-Sync system, using the PicoXR Neo 3 Pro Eye virtual-reality headset, to measure and quantify eye-movement biomarkers reflective of neurological impairment or disease.

MedRhythms’ digital therapeutics platform aims to improve walking and functional outcomes in patients with multiple sclerosis, Parkinsons’ disease and chronic stroke. With around $32m in funding to date, the start-up boasts collaborations with major medical centers and a partnership with Biogen.

Catherine Gregor is the chief clinical trial officer at Florence Healthcare, a leading provider of clinical trial software that helps researchers collaborate and manage workflows and information. Based on her extensive experience in clinical research administration, Gregor explains how the recent US FDA guidance on diversity and inclusion in clinical trials represents a critical opportunity to make clinical research more inclusive and equitable.

Medtech Insight interviewed Leonard Ganz, a veteran cardiac electrophysiologist who recently joined Abbott’s cardiac rhythm management business as its divisional vice president of medical affairs and chief medical officer.

In this month’s Digital Health roundup, Medtech Insight’s Reed Miller talks about iRhythm and Withings’ smartwatches business, Barnaby Pickering reviews digital therapeutics Pear Therapeutics’ restructuring, and Marion Webb presents highlights from her new series on Agetech.

As the global population ages, a crop of tech startups is rising to meet seniors’ needs and improve quality of life, including by keeping them upright and mobile.