A joint meeting of 2 FDA advisory panels backs the use of Avedro's cross-linking technology to treat 2 eye conditions.
Avedro said a joint meeting of 2 FDA advisory panels
considering its corneal cross-linking technology to treat 2 eye conditions this week voted to recommend approval.
UnitedHealth Group, the largest health insurer in the U.S., tightens its controls on hysterectomies performed using laparoscopic power morcellators.
India is reportedly considering raising its import tariff on medical devices by 5%.
The government of India is reportedly considering a 5% hike to the basic customs duty on imported medical devices, which make up 80% of its medtech market.
Medical device imports into India are hit with a tariff ranging from 5% to 10%, according to the Economic Times.
St. Jude Medical agrees to settle product liability lawsuits filed over its recalled Riata defibrillator leads and a class-action shareholder's suit accusing it of inflating results for its 2009 3rd quarter.
Royal Oak Medical Devices touts its 'repless' generic sales model, saying it can save its hospital customers more than $100,000 a year on their orthopedic implant spends.
Royal Oak Medical Devices says it can save its hospital customers more than $100,000 a year on their orthopedic implant spends, using its so-called 'repless' generic sales model.
Nikon, best known for its cameras, moves into medtech with Optos buy
(Reuters) - Nikon, the 98-year-old Japanese company best known for its cameras, has agreed to buy British retinal imaging firm Optos for 259.3 million pounds ($400 million) as it moves into the medical sector.
Nikon has previously said it intended to enter the medical sector to leverage its optical technologies and the Japanese group sees buying Optos as an important step in that long-term growth plan.
Kazuo Ushida, president of Nikon, said the company would expand the medical business further in the future.
Teleflex expands a Class I recall for Maquet Servo 163 humidifiers and beats expectations with its 4th-quarter earnings on the strength of 45% profit growth.
A single human error in India prompts GE Healthcare to issue a warning on 30 years worth of its MRI scanners.
Vector is Children's Hospital Boston's blog about research and innovation in pediatric and adult medicine. We report and comment on medical innovations and advances – from bench to bedside – touching on scientific, business and policy issues. Our ranks include science writers, physicians, lab researchers, market analysts and others inside and outside the hospital.
About a third of children with epilepsy do not get better with drug treatment. Many physicians are inclined to try additional drugs to control the seizures – and there are many to choose from. However, analysis of data from tens of thousands of patients suggests that if two or more well-chosen drugs have failed, and surgery is a safe option, there's no benefit in holding off.
Staar Surgical posts net losses for the 4th quarter and 2014 but comes close to meeting earnings expectations and discloses a 'voluntary hold' on a couple thousand of its implantable collamer lenses due to a manufacturing snafu.
Bellerophon Therapeutics shares are down nearly 21% since their $12-per-share debut earlier this month.
Bellerophon Therapeutics (NSDQ:BLPH) shares are down nearly 21% since its IPO 2 weeks ago, when the stock in the New Jersey-based drug-device company opened at $10 per share, down 16.7% right out of the gate.
NxStage Medical beats expectations with its 4th-quarter and full-year results and opens 2 new dialysis centers in the Boston area, sending share prices up today.
Wearables maker Sotera Wireless acquires sensor developer Reflectance Medical Inc.
Wearables maker Sotera Wireless said yesterday that it acquired sensor developer Reflectance Medical Inc. for an undisclosed amount.
Boston Scientific says the FDA cleared the SpyGlass DS version of its cholangioscopy and pancreatoscopy device.
Boston Scientific (NYSE:BSX) said the FDA granted 510(k) clearance for the latest iteration in its line of cholangioscopy and pancreatoscopy devices, the SpyGlass DS.
Globus Medical agrees to pay nearly $53 million for Branch Medical Group, a key supplier for its spinal implants.
Globus Medical agrees to pay nearly $53 million for Branch Medical Group, a key supplier for its spinal implants.
Lawyers for 2 patients, 1 of whom died, sue Olympus over the so-called 'superbug' infections they allegedly picked up from its endoscopes during surgical procedures.
(Reuters) — Attorneys for 2 patients infected with a drug-resistant bacterial "superbug" during medical procedures in a Los Angeles hospital, 1 of whom died, have sued the maker of the devices used in their care.
Here's a look at some of the top Wall Street stories for medical device companies this week: ViewRay registers for $69m IPO; Bellerophon prices $60m IPO low, issues more shares; Cutera expands stock buyback to $40M
NuVasive closes out 2014 with solid 4th-quarter results, but still posts a net loss for 2014, and misses analysts' expectations with its 2015 forecast.
Cyberonics agrees to an all-stock acquisition of Italian medical device maker Sorin that's worth about $1.4 billion.
Industry trade association AdvaMed applauds a bill introduced into the U.S. House of Representatives that would protect FDA user fees from sequestering cuts.
Industry trade association AdvaMed said Wednesday it applauds a bill introduced into the U.S. House of Representatives that would protect FDA user fees from sequestering cuts.
The FDA clears Cynosure's 532 nm Laser Delivery System for its PicoSure tattoo-removal technology platform.
The FDA has cleared Cynosure's (NSDQ:CYNO) 532 nm Laser Delivery System for its PicoSure tattoo-removal technology platform.
Cynosure said the regulatory win will enable the PicoSure system to remove all colors of ink in fewer sessions.
Second Sight Medical said the first commercial implants of its “bionic eye” prosthetic retina neurostimulation device have taken place in France.
Second Sight Medical (NSDQ:EYES)
has reached a milestone in France: the first commercial implants of its “bionic eye” prosthetic retina neurostimulation device.
Health insurer Cigna has issued a positive coverage decision on Uroplasty's over-active bladder (OAB) treatment, Percutaneous Tibial Nerve Stimulation (PTNS).
Health insurer Cigna has issued a positive coverage decision on Uroplasty's (NSDQ:UPI) overactive bladder (OAB) treatment, Percutaneous Tibial Nerve Stimulation (PTNS).
TEI Biosciences says it has been awarded a supply contract by group purchasing organization Novation for its biologic mesh products.
Regenerative medicine company TEI Biosciences said that it has been awarded a supply contract by group purchasing organization Novation for its biologic mesh products.
The FDA has granted market clearance to Bioness' StimRouter device for the treatment of chronic peripheral pain.
The FDA has granted market clearance for Bioness' Stimrouter for the treatment of chronic peripheral pain.
The company describes StimRouter as a minimally invasive, implanted neuromodulation device that sends electrical signals to the pain's point of origin. The device is controlled by a wireless, hand-held unit.
FDA's official blog brought to you from FDA's senior leadership and staff stationed at home and abroad – sharing news, background, announcements and other information about the work done at the FDA on behalf of the American public.
By William Maisel, M.D., M.P.H.
Here's a look at some of the top regulatory stories for medical device companies this week: Recent progress on demographic information and clinical trials; Moving toward a national medical device postmarket surveillance system; Medtronic wins CE Mark for Euphora Semicompliant balloon catheter; Simplify Medical wins CE Mark for MRI-safe cervical disc
MassDevice.com chats with Jason Rupp, the 1st full time executive director for the Southeastern Medical Device Association (SEMDA)
The Southeastern Medical Device Association (SEMDA) is making a move to become 1 of the preeminent trade associations supporting the medical device industry.
The non-profit trade association - that supports and promotes medical device companies in the Southeastern United States - recently named former AdvaMed executive Jason Rupp as its first full time executive director.
An AdvaMed official predicts that India’s medical device market could be worth $30 billion in a decide, if government can find the right recipe of regulations and policies to nurture the industry.
While the medical device industry in India is worth about $4 billion today, that number could climb to $30 billion in a decade with regulations and government policies that spur investment and growth.
Uroplasty and Vision-Sciences shareholders will vote on the proposed merger between the 2 companies on March 30, according to a regulatory filing.
Uroplasty and Vision-Sciences shareholders will vote on the proposed all-stock merger deal between the two companies on March 30, according to a regulatory filing.
C. R. Bard is reportedly close to settling a suit filed in a West Virginia federal court by a woman who claimed she was injured by the company's pelvic-mesh device, Avaulta Plus.
C.R. Bard (NYSE:BCR) is reportedly close to settling a suit filed in West Virginia federal court by a woman who claimed she was injured by the company's pelvic-mesh device, Avaulta Plus.
The FDA has cleared Neuronetrix's portable device for the recording of electrical brainwaves in patients with neurological conditions such as Alzheimer's disease, concussion, schizophrenia and ADHD.
The FDA has cleared Neuronetrix's portable device for the recording of electrical brainwaves in patients with neurological conditions such as Alzheimer's disease, concussion, schizophrenia and ADHD.
The device, called the Cognision System, is designed to run brainwave tests such as EEGs and auditory event-related potentials (ERPs). Neuronetrix said the device allows doctors to run tests in their offices that used to be only available in a hospital setting.
A FDA advisory panel has recommended the agency approve VertiFlex's Superion interspinous spacer system for the treatment of spinal stenosis.
A FDA advisory panel has recommended the agency approve VertiFlex Inc.'s Superion interspinous spacer system for the treatment of spinal stenosis.
According to VertiFlex, the panel based their vote largely on results from the company's 470-patient clinical trial.
HeartWare International has issued an urgent recall for certain computerized controllers for its ventricular assist devices over concerns that they may malfunction and cause the heart pump to stop.
HeartWare International (NSDQ:HTWR) has issued an urgent recall for certain computerized controllers for its ventricular assist devices over concerns that they may malfunction and cause the heart pump to stop.
EnteroMedics ended 2014 in the red, though it gearing up commercialization plans for its signature neurostimulation anti-obesity implant.
EnteroMedics (NSDQ:ETRM) lost money again in 2014 but the Minnesota developer of a neurostimulation implant to treat obesity expects to address the red ink in the coming months, as it gears up for a commercial launch of its signature device.
FDA's official blog brought to you from FDA's senior leadership and staff stationed at home and abroad – sharing news, background, announcements and other information about the work done at the FDA on behalf of the American public.
By Jeffrey Shuren, M.D., J.D. and Thomas P. Gross, M.D., MPH
P.T. Barnum is alleged to have said, "There's a sucker born every minute." Yet even he would be astounded by the way in which cities compete to host the Olympic Games. One of the latest suckers is my home city, Boston.
By Mike Travis
P.T. Barnum is alleged to have said, "There's a sucker born every minute." Yet even he would be astounded by the way in which cities compete to host the Olympic Games. One of the latest suckers is my home city, Boston.
Medtronic’s DBS therapy for treatment-resistant epilepsy has produced long-lasting improvements in quality of life after 5 years, according to detailed results from a pivotal clinical trial.
Here's a look at some of the top legal news stories for medical device companies this week: The telltale heart device; Pelvic Mesh lawsuits: J&J drops claim that women were asked to lie for payouts ; Boston Scientific to pay J&J $600 million to settle Guidant suit
Medicare plans to provide supplemental reimbursement to hospitals for patients treated on an outpatient basis with Medtronic's new In.Pact Admiral drug-coated balloon for peripheral artery disease (PAD) in the upper leg.
The FDA warns ERCP endoscopes may allow for the transmission of certain drug-resistant "superbugs," even if the devices are properly cleaned.
The FDA is warning that ERCP endoscopes may allow for the transmission of certain drug-resistant "superbugs," even if the devices are properly cleaned.
The advisory was issued in the wake of news that contaminated endoscopes are suspected of causing a deadly outbreak of the superbug CRE, or carbapenem-resistant enterobacteriaceae (CRE), among patients at the UCLA Ronald Reagan Medical Center in Los Angeles.
Federal regulators say they have approved the VenaSeal closure system to treat varicose veins
Covidien's VenaSeal closure system to treat varicose veins has been approved by the U.S. Food and Drug Administration, according to an agency press release.
CeQur SA is touting preliminary results from study that evaluates long-term glycemic control produced by its wearable insulin delivery device.
CeQur SA, developer of a 3-day, wearable insulin delivery device, is touting promising preliminary results from a new study evaluating its glycemic control over three months.
The Horw, Switzerland-based company, said that early data from the trial shows its PaQ device consistently improved glycemic control in patients with type 2 diabetes. That conclusion comes from a single-arm treat-to-target 12-week pilot study involving eight people with the condition.
Infraredx delays $56M IPO, according to a report from invesment advisory firm Renaissance Capital
SCHAFFHAUSEN, Switzerland – February 18, 2015 – TE Connectivity Ltd. (NYSE: TEL), a world leader in connectivity, announced today that it has entered into a definitive agreement to acquire AdvancedCath for $190 million USD in cash.
AdvancedCath is a leading source of advanced catheter systems, with estimated 2015 revenues of $60 million. The company combines best-in-class technologies with industry-leading expertise in lifesaving therapy areas.
The acquisition complements and significantly expands TE's connectivity and sensor position in the attractive, high-growth interventional space of the medical market. Further, it will allow TE to provide more complete integrated solutions to customers.
Here's a look at some of the top legal news stories for medical device companies this week: Smith & Nephew gets in on Michelson Diagnostics Series B round; Diabetes: Valeritas registers $90m IPO; HeartFlow raises $36m for non-invasive FFR system; Bellerophon prices $60m IPO low, issues more shares; Rainbow Medical raises $25m for China ops
Google-backed 23andMe won U.S. approval to market direct-to-comsumer genetic test
(Reuters) - Google (NSDQ:GOOG)-backed 23andMe won
U.S. approval on Thursday to market the first direct-to-consumer
genetic test for a mutation that can cause children to inherit
Bloom syndrome, a rare disorder that leads to short height, an
increased risk of cancer and unusual facial features.
