A single-port laparoscopic device designed to knock down a key barrier in the space has earned a financial boost just days ahead of the product's official U.S. launch. Chemelot Ventures led Fortimedix Surgical B.V.'s €11 million series A round to support the company's FMX314, which recently won both FDA clearance and a CE mark, and is compatible with a standard-sized trocar that laparoscopic surgeons are most familiar with. Fortimedix, of Nuth, Netherlands, plans to launch the device in the U.S. at the American College of Surgeons Clinical Congress next week in Washington, with a European launch to follow in 2017....

San Diego-based Biocept Inc. has been on a roll this year to carve out a spot for itself in the emerging field of liquid biopsy and personalized medicine. A $10 million offering of common stock and warrants is the company's latest move to support its expanding menu of available companion tests for immuno-oncology therapeutics. The company said Friday it would sell stock (9.1 million shares) and warrants (for 9.1 million shares) at a combined price of $1.10. The warrants will be good for up to five years. The offering, which is expected to close...

Electrophysiology devices made by Minneapolis-based St. Jude Medical Inc. are back in the bad news column due to an unexpected depletion of batteries the company said is associated with a buildup of lithium deposits. The problem could lead to complete battery failure within an hour of the sounding of an alert, but Wall Street sees the problem as limited as demonstrated by the fact that the announcement drained only about three percent from the value of the company's shares at the New York Stock Exchange. One of the first sources to break the story was...

The comment period for the FDA draft guidance addressing the use of public gene-variant databases to support clinical validity for next-generation sequencing (NGS) systems is closed, but at least one stakeholder sees a major point of ambiguity that could stymie regulatory review of these high-volume DNA tests. San Diego-based Illumina Inc. said in its comments to the docket that the draft fails to spell out what sort of role these databases will play, speculating that they could serve as anything from industry-wide standards to special controls for specific tests, a difference that could have important...

Growing up really is hard to do – especially for a small med-tech company in a big pond – but ICU Medical Inc. has "finally delivered" in a transformative way, according to analysts reacting to ICU's $1 billion deal to acquire Pfizer Corp.'s infusion therapy business, Hospira Infusion Systems. "Small companies either have to get bigger or get consolidated, and it's incredibly hard for small companies to get bigger in maturing markets," ICU CEO Vivek Jain said during a conference call Thursday. The acquisition will create a pure-play infusion therapy company with combined revenue...

Transenterix Inc.'s Senhance recently scrubbed in, so to speak, to lend its robotic hands to a gynecologic surgeon in Italy during a major cervical cancer procedure. It was the first time the company's recently re-branded surgical robotic system has been used during a radical hysterectomy and, if the surgeon's feedback is any indication, it probably won't be the last time the Senhance is involved with a complex gynecologic oncology case. A radical hysterectomy involves an extensive pelvic lymph node dissection and removal of the patient's uterus and parametrium, ovaries, fallopian tubes, and part of...

Johnson & Johnson's diabetes unit warned patients this week that the Animas Onetouch Ping insulin pumps may be vulnerable to a cyberattack, but the probability of one of the devices actually being hacked is "extremely low," the company said. The pump could potentially be accessed through its unencrypted radio frequency communication system, but such an attack would require technical expertise, sophisticated equipment and proximity to the device, according to a letter the West Chester, Pa.-based Animas Corp. sent to patients on Monday. The company noted that the Onetouch Ping system is not connected to...

About 15 years ago Chris Toumazou imagined that if the electronics industry could scale down electronic circuits so that they were smaller, faster, and cheaper to produce – paving the way for consumer-based products like mobile phones and tablets – it might be possible to apply microchips to the health care industry. Inspired by that idea, Toumazou, a professor at Imperial College London, invented a way of detecting protons released during DNA synthesis to enable DNA sequence detection using a standard silicon-chip based transistor. This optics-free, label-free method shifted DNA sequencing from specialized, expensive...

Wednesday was a great day for the diabetes community, Richard Bergenstal, a research clinician at the International Diabetes Center at Park Nicollet, told Medical Device Daily, soon after the FDA approved the first commercial device often referred to as an artificial pancreas. Medtronic plc's Minimed 670g hybrid closed loop system is now approved for patients 14 years of age and older with type 1 diabetes. The device is designed to adjust insulin levels with little or no input from the user by measuring glucose levels every five minutes. The regulatory milestone came about three...

SILVER SPRING, Md. – Can the development of antimicrobials and susceptibility tests be coordinated more effectively? Yes, according to attendees of an FDA workshop Thursday on challenges and opportunities for getting clearance for antimicrobial susceptibility tests (ASTs) shortly after antimicrobial drug approval. "It takes a village," was a phrase tossed out several times during the event, in which clinicians, laboratory representatives, regulators, and members of the pharmaceutical and medical device industries offered potential solutions. The meeting came about a week after the release of draft guidance that is intended to give the FDA recommendations on...