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Digital Health Roundup: Digital Therapeutics Push Ahead On Standards, Coverage; FDA’s Software Guidance

In this roundup feature focusing on developments in digital health, we highlight the key news and announcements from October.

Digital Health Artificial Intelligence

FDA Clears Withings' Smart Watch For Detecting AF and Measuring Blood Oxygen

The French company is promoting its ScanWatch as the first wearable device to receive FDA clearance for both atrial fibrillation detection through medical grade ECG and measuring SpO2 levels from the wrist.

Approvals Retail

Medical Device and In Vitro Diagnostics/Research Deals Statistics Quarterly, Q2 2011

During the second quarter of 2011, 57 medical device companies brought in a total of $1.7 billion in financings. The M&A activity reached $28.8 billion, unusually high due to Johnson & Johnson's $21.7 billion takeover of orthopedic device maker Synthes. VC funding represented $76 million or 43% of the second quarter's in vitro diagnostics/research financing aggregate of $177 million. A hefty $4.1 billion was spent on 11 in vitro diagnostic/research M&A transactions, the largest being Thermo Fisher's $3.5 billion buy of Swedish genetics testing firm Phadia AB.

Medical Device

Medical Device and In Vitro Diagnostics/Research Deal Statistics Quarterly, Q2 2010

Highlights from the Q1 2010 review of medical device and in vitro diagnostics/research dealmaking: With most of the funding in the form of venture rounds, medical device financing totaled $548 million in the second quarter, a 10% drop from Q1. Device acquisitions picked up, with 18 transactions completed for an aggregate $4.4 billion. Including GenMark's IPO, the first done in the sector since November 2007, in vitro diagnostic/research financing more than doubled Q1's dollar volume, reaching $364 million in the second quarter. The four IVD/Research acquisitions done in Q2 totalled $226 million.

Medical Device
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