Conor Hale

6 days ago | fiercebiotech.com | Conor Hale

As it aims to broaden the reach of its replacement heart valves among younger patients, Edwards Lifesciences has put forward new clinical data showing its bioprosthetics can maintain their function over the long term. The company highlighted a study spanning eight years that compared the performance of surgical aortic valves made with its proprietary Resilia tissue to those without, showing reduced rates of deterioration and the need for fewer follow-up operations.

1 week ago | fiercebiotech.com | Conor Hale

Click Therapeutics has collected a groundbreaking green light from the FDA for the agency’s first prescription digital therapeutic aimed at preventing migraines. Designed to be used alongside standard drug therapies, a randomized, sham-controlled trial of Click’s smartphone app showed it could significantly reduce an adult’s number of episodic migraine days per month.

1 week ago | fiercebiotech.com | Conor Hale

Precision Neuroscience has obtained an FDA clearance for a crucial piece of its plans for a full brain-computer interface system, starting with its minimally invasive cortical electrode array. The company described it as the first regulatory green light for a developer of wireless mind-reading tech. The agency cleared Precision’s Layer 7 interface as a temporary implant, for use up to 30 days.

1 week ago | fiercebiotech.com | Conor Hale

The imaging provider RadNet aims to acquire iCad and its artificial intelligence-powered mammography software—with plans to fold them into its DeepHealth subsidiary, along with their commercial and engineering teams. The all-stock transaction is valued at about $103 million, or a 98% premium over iCad’s recent share price. The deal is slated to close in the third quarter of this year.

1 week ago | fiercebiotech.com | Conor Hale

Like Johnson & Johnson did during its earnings call the day before, Abbott estimated that global tariffs would end up costing “a few hundred million dollars” in the latter half of this year, according to CEO Robert Ford—though he said he was confident the company could partially weather the storm by investing in its distributed production network.