With the announcement that the FDA granted 510(k) approval for the AliveCor EKG case for the iPhone 4/4s, the device became available to "licensed U.S. medical professionals and prescribed patients to record, display, store, and transfer single-channel electrocardiogram (ECG) rhythms."
MASSDEVICE ON CALL — The FDA’s medical device review arm unveiled a new organization scheme, adding a pair of new review divisions and 12 new branches.
The Center for Devices & Radiological Health began operating under the new plan at the start of the month, featuring separate divisions for surgical and for neurological/physical medicine devices.
The agency hopes to "reduce the manager to staff ratios and better align product areas as well as accommodate the new MDUFA hires that will be coming into the Center," according to the FDA Law Blog.
Updated: 08/02/2011 1:30 p.m.
Accuray Inc. (NSDQ:ARAY) priced its proposed offering higher than previous estimates, coming in at $100 million in 3.75 percent convertible senior notes made available to institutional investors.
The sale was set to close yesterday, according to SEC filings.
Withings, a French company focused on using new smartphone technologies, announced 510(k) clearance for its blood pressure monitor for the iPad, iPhone and iPod touch.
The monitor, which the company unveiled in January, measures and records blood pressure readings for professional, home or mobile use.
The system was submitted for Food & Drug Administration 510(k) review in mid-May and is available for sale in the U.S. just one month later.