Gynaecology/Obstetrics

Deliverer of light to MIS surgical sites, Invuity, Inc. has announced an agreement with one of the U.S.’ most prominent and nationally recognized purchasing organizations, Yankee Alliance, that will see its products being made available to thousands of its members.

CareFusion says its new line of Micro-Laparoscopic instruments means it is on trend with miniaturized procedures.

The Eeva System enables IVF clinicians the first prognostic, non-invasive test that provides objective information regarding embryo development potential.

A first patient has been enrolled in the Embrace™ study into AMS’s Elevate™ Anterior and Apical Prolapse Repair System.

Proa® Medical, Inc., developer of innovative and practical medical devices for women’s health, says it has received U.S. FDA 510(k) clearance to market its single-use device, the Brella-Spec™ Vaginal Speculum.

Uterine Fibroid specialist company, Halt Medical has announced that the U.S. FDA has granted 510(k) clearance for the Acessa Guidance Hand Piece, an accessory for the treatment of symptomatic uterine fibroids.

A Reuters article tells us that Johnson & Johnson has suspended the sale of its power morcellators until the risk of spreading cancerous cells is better understood. This in response to earlier FDA guidance on the subject.

CrossBay Medical, Inc., has announced a bevvy of regulatory clearances. The company’s SonoSure™ Sonohysterography and Endometrial Sampling Device now has U.S.FDA and Health Canada clearance as well as CE mark approval.

In what is claimed to be the largest in the world on surgical simulation for robotic surgery, an Italian team has concluded that aptitude on virtual reality tests can provide a measure of innate ability or as they term it, manipulative and psychomotor skills.

daVinci company Intuitive Surgical is to acquire a “shape-sensing” technology from its developer, Luna Innovations Inc. in a deal worth up to $30 million.

Covidien has received U.S. FDA 510(k) clearance for the LigaSure™ Maryland jaw open/laparoscopic sealer/divider. In addition the company has completed all European requirements to CE Mark the product. It expects to launch the new vessel sealer and divider in the United States and the European Union during the current quarter.

The FDA has granted 510(k) Clearance of the American Medical Systems® RetroArc™ Retropubic Sling System for treatment of female stress urinary incontinence (SUI). The company says its system incorporates enhancements and the ability to make fine-tuned adjustments to better meet the needs of physicians.

Intuitive Surgical has written to customers worldwide, and in the US the FDA has issued a Class II recall notice which contains the instruction that users should contact the company to arrange an inspection visit and repair or replace daVinci robotic surgery device components as necessary to avoid a friction-induced stalling problem.

Law firm Bernstein Liebhard LLP has issued a press release that brings us up to date, pointing in particular to a piece of research that suggests 30% of robotic surgery complications using Intuitive’s da Vinci system, as reported on the FDA’s MAUDE database, were either a result of operator error or technical failure of the robotic system itself.

Medtech Market Intelligence company Millennium Research Group (MRG), has launched a new report which looks into the future for laparoscopic surgery devices in the United States. MRG believes the market will see moderate growth, culminating with a market value of $4.5 Billion by 2022.

Guided Therapeutics has still not addressed all of the FDA’s concerns as it attempts to gain PMA approval for the LuViva cervical scanning device. It’s consoling itself with revenue from a newly enhanced push into more international markets.