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Thermo Fisher Scientific announced it will purchase The Binding Site Group, a UK-based developer of specialty assays and instruments for diagnosis and management of blood cancers and immune system disorders, for $2.6 billion. Read More
Massachusetts-based Abiomed’s Impella RP Flex with SmartAssist heart pump has received FDA’s premarket approval to provide temporary right ventricular support for up to 14 days. Read More
BioIntellisense announced the launch of its FDA-approved pulse oximetry device, an optical sensor the company says accurately measures blood oxygen levels across the full range of skin colors from light to very dark. Read More
The average total review time declined from 170 calendar days in 2018 to 126 in 2022, but there was a pandemic-related spike to 190 days in 2020. Read More
The Center for Devices and Radiological Health (CDRH) is encouraging research on the use of digital health technologies (DHT) to advance patient engagement, leverage connectivity and improve healthcare, according to a report the center released last week. Read More
Representatives from Medtronic and Masimo, both manufacturers of pulse oximeters for more than three decades, defended the accuracy of their devices for patients of all skin tones at an FDA advisory panel meeting yesterday. Read More
Johnson & Johnson (J&J) announced Tuesday that it would acquire Massachusetts-based Abiomed, gaining access to the medical device company’s Impella heart pump, which treats conditions such as heart attack, heart failure and clogged arteries. J&J will pay $380 per share upfront in cash, which equates to a value of approximately $16.6 billion. Read More