Hologic slashes outlook as losses widen
Hologic is still sorting out its business units after buying Gen-Probe for $3.8 billion, and the company took a deeper loss in the first quarter despite a 30% increase in total sales.
Mass General repurposes cancer Dx tool for multiple use
Massachusetts General Hospital researchers repurposed a portable, fast-acting diagnostic device they developed to spot cancer as a successful test for tuberculosis and other infectious diseases such as pneumonia. Additionally, they used it to pinpoint antibiotic resistant bacteria such as the deadly MRSA.
J&J gains pivotal PMA for computer-aided surgical sedation device
Johnson & Johnson achieved a pivotal FDA PMA approval for what is being billed as the first computer-assisted sedation system, now available for endoscopy procedures.
Medtronic wins FDA nods for next-gen cardiac devices
Medtronic is padding its fleet of U.S.-approved cardiac devices, winning the FDA's blessing to market new Viva and Evera implants.
Florida sales tax exemption aids medical device manufacturing base
Florida state lawmakers have agreed to a sales tax exemption for manufacturing equipment, something medical device makers had clamored for to help keep the state's manufacturing base competitive domestically and internationally.
Spanish Dx startup grabs a $22.1 M Series B
Investors committed more than $22 million in new venture financing to a Spanish startup focused on developing a speedier diagnostic system for infectious diseases, antibiotic resistance and critically ill patients. The money will help back a commercial launch slated for 2015.
Covidien eyes June 28 for pharma spinoff
Covidien is ready to pull the trigger on its long-planned pharmaceutical spinoff, planning to jettison its Mallinckrodt business June 28, and the company is amending its financials to prepare for a drug-free future.
India draws industry ire with stent reimbursement reduction
Resentment appears to be growing among multinational medical device companies over India's decision in February to slash reimbursement for drug-eluting stents.
Nose neurons offer scent of schizophrenia Dx possibility
Harvesting neurons from the nose through a routine biopsy could allow for a speedy, accurate way to definitively diagnose schizophrenia in living patients, scientists from Tel Aviv University in Israel and Johns Hopkins University in Baltimore, MD, have discovered.
Haemonetics to shutter Massachusetts plant
Haemonetics will shutter a plant in Braintree, MA and eliminate 320 jobs the facility supported over the next 18 months. But it will expand operations in Mexico and Asia.
Medtronic lops off 230 spinal jobs, endures FDA blemish
Medtronic is following through on its long-held plans to slash jobs in its spinal business, cutting 230 positions as revenues falter. Meanwhile, the FDA slapped its most serious recall label over a potentially deadly flaw with the device giant's deep-brain stimulators.
Zimmer grabs PA startup for cutting-edge knee treatment
Zimmer snatched up a Pennsylvania startup with a cutting-edge knee treatment surgical procedure, giving the medical device, implant and surgical product manufacturer a big boost to its own offerings in the space.
Life Tech's income slides as Thermo's wallet waits
Life Technologies is set to become part of Thermo Fisher come 2014, but for now, the company is still trying to balancing spiking costs and tepid revenue growth, watching profits slip 8.6% in the first quarter.
Dx to predict prostate cancer recurrence produces hopeful results
Prostate cancer treatment is in serious need of a diagnostic test that could better predict the chances it will recur. A new molecular diagnostics test designed to address this has generated some encouraging results in a study involving 270 tumor samples.
FDA panel rips Delcath drug/device cancer treatment
In what could be a deathblow for Delcath Systems, an FDA panel of experts voted unanimously that the risks of the company's drug-device combo to treat cancer outweighed any benefits.
Implant successfully predicts human epilepsy seizures
NeuroVista's implantable device successfully and correctly predicted epilepsy seizures in some adults for whom drugs haven't worked, a new proof-of-concept study found.
BioFire Diagnostics turns $25M financing into $45M cash infusion
BioFire Diagnostics has been able to transform $25 million financing first announced last fall into a much larger $45 million cash infusion, all to help the company quicken the commercialization and rollout of its molecular diagnostics platform.
Cardiovascular Systems' Q3 revenue grows
Cardiovascular Systems generated a big revenue jump in its fiscal 2013 third quarter, positive news as the company waits for the FDA's approval decision on its new device to treat calcified coronary arteries.
Study: Zinc may be ideal for bioabsorbable stents
Zinc may be the ideal ingredient for bioabsorbable stents, new research from Michigan Technology University concludes.
St. Jude targets FDA approval for next-gen CRT-D
St. Jude Medical is kicking off a large-scale study of its Quadripolar Pacing System, aiming for FDA approval for a device the company says could improve outcomes for patients who don't respond to standard treatment.
