A medical device company has received a warning letter over its device designed to cool patients down in a short amount of time, particularly in preparation for surgery and other clinically indicated uses.The letter said the company has not adequately responded to a malfunction in the ThermoSuit’s pump that led to a patient being overcooled [...]

Teleflex (NYSE:TFX) has replaced its chief financial officer after a little more than two years with the company.Richard A. Meier’s employment was “terminated” March 9, according to a statement from the company. Thomas E. Powell will take over the role.Powell joined the company last year as the vice president for global finance. Powell had previously [...]

Swiss medical device manufacturer Synthes has received a warning letter from U.S. regulators taking issue with the company’s management of complaints over its devices and problems with orthopedic surgery devices.It said a review of its factory in West Chester, Pennsylvania between June and September 2011 revealed that some complaints “were not promptly reviewed, evaluated, or [...]

A health plan is expanding its use of telemonitoring for high-risk patients to include diabetes and hypertension following a 44 percent reduction in readmission of congestive heart failure patients within 30 days of being discharged from the hospital.Geisinger Health Plan conducted a two-year trial with AMC Health, a company that coordinates remote healthcare services and [...]

A medical device company producing electronically adjusted optical lenses is poised for national expansion, Safeguard’s chief financial officer Stephen Zarrilli said in a conference call discussing the Safeguard Scientifics’ (NYSE:SFE) fourth-quarter earnings.The product — a lens that electronically adjusts to the wearer’s eyesight — is aimed at people suffering from presbyopia, a condition in which [...]

U.S. regulators have reached a civil settlement with a bone graft company, in which the CEO received a $450,000 fine, for distributing its orthopedic devices without approval as part of a $1 million settlement against the orthopedic device firm.The company was fined $550,000 for marketing its NuBone Osteoinductive Bone Graft product without proper premarket approval [...]

A medical device company developing an implant for optimized angioplasty to treat peripheral artery disease has raised $2.5 million since September.The device is a permanent implant that would tack up the plaque blocking or restricting blood flow. The plaque would be tacked up along the walls of the relevant blood vessel, providing for better blood [...]

Ophthalmic imaging technology company Bioptigen now has regulatory clearance in Canada on a handheld medical device developed to give doctors better images of their patients’ eyes.The medical license from Health Canada allows Bioptigen to begin marketing its Envisu devices in Canada. The clearance follows a CE Mark awarded in Europe in December, which clears the [...]

A medical device company run by serial entrepreneur David Fischell has raised $1.4 million for the development of its catheter system to treat hypertension.The fundraising target for the series A round is $2.5 million, according to a Form D filing with the U.S. Securities and Exchange Commission.David Fischell is the co-founder of and board director [...]

U.S. regulators have given premarket approval to a streamlined, programmable and implantable drug-delivery pump to treat and manage back pain, the first new development in such pumps since a device from Medtronic (NYSE:MDT) hit the market more than 15 years ago.The Prometra drug-delivery pump has been approved for use with Infumorph, a pain medication. It [...]