Category: Surgical

Ex-FDA commissioner joins board of Michigan cancer treatment firm

September 1, 2010 by MassDevice staff

HistoSonics Inc. brought former Food & Drug Administration commissioner Dr. Andrew von Eschenbach onto its board yesterday.

The ex-commissioner's experience as a surgeon, urological oncologist and healthcare administrator made him a good fit, said the Ann Arbor, Mich.-based company, which is developing a treatment for urological cancer.

CEO Tom Davison said "[Dr. von Eschenbach's] commitment to safe and effective healthcare and especially cancer therapy aligns precisely with HistoSonics’ vision and long term strategy," in a prepared statement.

ClearCount Medical rings in a $5 million Series B round

August 31, 2010 by MedCity News

ClearCount Medical Solutions Inc. closed its Series B funding round with a hoped-for $5 million.

ClearCount is developing the SmartSponge and SmartWand systems, which use radio-frequency identification technology and chips embedded in sponges to allow surgeons and nurses to detect and count sponges during surgeries.

Two Ohio device firms vie for for state loans

August 31, 2010 by MedCity News

Two Northeast Ohio medical device companies are under consideration for state loans worth a combined $1.1 million.

Columbus-based skin biopsy device maker CleveX Inc. is seeking a $637,500 loan to purchase equipment and machinery to boost production capacity for its ExiClip line of devices. The company aims to continue producing a version called the ExiClip-M, while also developing a new version for larger biopsies called the ExiClip-L.

FDA warns Starion Instruments on malfunction reporting, complaints procedures

August 23, 2010 by MassDevice staff

The Food & Drug Administration sent a warning letter to Starion Instruments Corp. after determining that the company failed to correctly report a series of malfunctions of its thermal ligating shears.

Topex offloads its skin cancer treatment segment

August 20, 2010 by MassDevice staff

Topex Inc. is no longer in the skin cancer treatment business.

The Danbury, Conn.-based company sold its low-energy SRT 100 superficial radiotherapy treatment system business to Boca Raton, Fla.-based Sensus Healthcare LLC for an unspecified amount.

Owens & Minor lands $547 million in Pentagon deals

August 19, 2010 by MassDevice staff

Owens & Minor (NYSE:OMI) landed $547.2 million worth of U.S. Dept. of Defense contracts, the federal agency revealed.

The two-year contracts representing $442.6 million, $68.4 million and $36.2 million are for medical surgical supplies and services for every branch of the armed forces, plus "federal civilian agencies and other non-DOD agencies." Each contract is set to be completed April 19, 2012.

BSD Medical wins FDA clearance for ablation system, drums up $2.75 million

August 19, 2010 by MassDevice staff

BSD Medical Corp. (NSDQ:BSDM) landed 510(k) clearance from the Food & Drug Administration for itsits MicroThermX microwave ablation system, MTX-180.

The Salt Lake City-based cancer treatment device-maker said it optimized the MTX-180 system with higher power for interventional and surgical oncology. The device uses "synchronous phased array technology" to target microwave energy for soft-tissue ablation.