Latest from Brian Bossetta
Small Biz Bill A Big Win For Medtech Innovation: Bipartisan Legislation Awaits President’s Signature
The US Congress overwhelmingly passed legislation reauthorizing federal programs essential to smaller medtech firms in need of funding. AdvaMed says the bill is critical for medtech innovation.
The US FDA has issued an early alert concerning Intuitive Surgical staplers used during various procedures with the da Vinci Surgical System. The company is instructing customers to stop using the devices.
The Trump EPA wants to loosen restrictions the Biden administration placed on facilities that sterilize medical devices with ethylene oxide, arguing the rollbacks are necessary to ensure device accessibility and supply chain security. Opponents to the rollbacks say EtO is a danger to public health.
During the latest round of MDUFA negotiations, the FDA and medtech industry agreed to include language in the next commitment letter that would provide direction for the use of carryover funds from user fees. The parties also found agreement on several other topics.
As AI becomes ubiquitous in diagnosing diseases, clinicians must balance the technology’s enormous upside, such as improving the speed and accuracy of diagnoses, with the potential for errors that can lead to delayed or missed treatment.
HeartBeam’s CEO says the strength of clinical data convinced the US FDA to reverse course and grant clearance to his company’s innovative ECG device, which he says can assess arrhythmias at home with hospital accuracy.
