Brazil's ABIMO medtech industry association reports newly-buoyant levels of export activity, as normal business routines crystalize further in the post-COVID phase. Meanwhile, member companies of the Brazil Health Devices initiative are outperforming industry averages.

The European Commission has launched an initiative to ensure products without a medical purpose that fall under the Medical Device Regulation are appropriately classified by risk, and subject to the same pre- and post-market requirements as comparable medical devices.

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.

The device giant is recalling Cobalt and Crome defibrillators because they may deliver weaker shocks than intended.

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 labelled a recall of Becton Dickinson intraosseous needle set kits, manual driver kits, and powered drivers as class I, its most severe designation. 

Two Massachusetts-based infusion pump manufacturers with the same founder and CEO received warning letters from the US FDA for similar violations.

The European Commission has launched an initiative to ensure products without a medical purpose that fall under the Medical Device Regulation are appropriately classified by risk, and subject to the same pre- and post-market requirements as comparable medical devices.

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.

Two Massachusetts-based infusion pump manufacturers with the same founder and CEO received warning letters from the US FDA for similar violations.

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.

The US FDA has labelled a recall of Becton Dickinson intraosseous needle set kits, manual driver kits, and powered drivers as class I, its most severe designation. 

Fundamental VR, which developed a virtual surgical platform that uses advanced technologies such as haptic (touch) feedback, announced on 11 August it raised $20m in a series B round led by EQT Life Sciences and prior investors Downing Ventures.

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.