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New features of the Impella device include an optical pressure sensor and revised controller.
The clearance marks the first time the FDA has signed off on such an integrated system and creates a simpler path to market for future CGMs.
Polarean, a North Carolina-based devicemaker focused on the MRI market, said it plans to raise as much as $4.3 million in a public offering listing.
The government alleges Alere continued to sell Triage devices in the years running up to a 2012 recall despite receiving reports of erroneous results.
The nod clears the Intuitive Surgical founder’s latest venture to sell the device for use in bronchoscopic procedures in lung cancer patients.
The FDA set two new guidelines for device and drug makers on postmarketing safety reporting requirements for some combination treatments.
New draft guidelines in India are calling for at least 50% of some types of devices to come from Indian companies.
CMS has given the final go-ahead for coverage of Foundation Medicine’s pan-cancer genomic test that was approved by the FDA late last year.
Kass-Hout led the groundbreaking openFDA initiative and rehabilitated the reputation of the FDA’s IT department during his three years at the agency.
Regulatory officials view the online vision test app as a device and as such want Opternative to file for premarket approval.