The Medical Device Business Journal — Medical Device News & Articles | MassDevice
Tandem Diabetes Care upped the ante on its venture-backed initial public offering, increasing its maximum aggregate price to $123.2 million and pricing shares at between $13-$15 apiece.
The company, maker of the touch-screen t:slim insulin delivery system, will begin trading on the Nasdaq exchange under the ticker ‘TNDM’ following the IPO.
Tandem Diabetes Care this week filed registration documents ahead of an initial public offering that the San Diego company estimated may be worth up to $100 million. Tandem shares will be listed on the Nasdaq exchange under the ticker ‘TNDM’.
The registration has not yet become effective, according to the company.
Novo Nordisk landed FDA 510(k) for its NovoPen Echo, which the company touts as the 1st insulin pen to combine half-unit dosing with a memory log to help patients keep track of injection dose and time.
The Plainsboro, N.J.-based medical device maker said its new pen will be on the shelves in 2014. The FDA clearance follows green-lights from regulators in Canada, Europe and Israel.
After Nova Biomedical issued a voluntary recall letter for its Nova Max test strips and glucose meter kits, the FDA determined that the measure qualified as a Class I recall, a label reserved for issues that pose a threat of significant patient harm.
MASSDEVICE ON CALL — Smartphones are capable of meeting all the criteria for an artificial pancreas by providing close-loop, outpatient control of glucose levels for diabetics, according to a new study published by the American Diabetes Assn.
Nova Biomedical recalled its Nova Max blood glucose meter test strips after discovering a glitch in which the meters displayed abnormally high results.
The Waltham, Mass.-based medical device company reported that 21 lots were affected by the recall, asking any customer with affected products to immediately stop using the strips.
