Globus Medical shares gain on its better-than-forecast 3rd quarter as the orthopedics company announces the surprise resignation of CFO Richard Baron.
NuVasive swings to a 3rd-quarter loss on higher-than-expected taxes, but beats Wall Street's sales expectations and says it expects to recoup the loss next quarter.
Microsoft launches its 'Microsoft Band' wearable device for just under $200, saying the device is designed to track pulse rate, calories burned and sleep quality.
A federal judge rules that TIG Insurance Co. owes Stryker Corp. nearly $8 million to cover deals the orthopedics company made to settle product liability lawsuits concerning its Duracon Uni-Knee implants.
Zimmer reveals the management team and business structure it plans to put in place once its $13 billion merger with rival Biomet closes.
Hansen Medical says its 3rd-generation Sensei X2 robot-assisted surgery device won an FDA nod for use in heart procedures.
HeartWare posts narrowed 3rd-quarter losses thanks to increased sales of its implantable heart pumps in the U.S.
HeartWare International (NSDQ:HTWR) yesterday reported narrowed 3rd-quarter losses and significantly higher revenues, boosted by a 39% jump in U.S. sales of its implantable heart pumps.
Medtronic CEO Omar Ishrak unveils the plan for the medical device giant's management structure after it closes its mega-merger with Covidien early next year.
Coloplast posts its 1st profits decline in 7 years on mounting legal costs stemming from U.S. product liability lawsuits filed over its pelvic mesh products.
Here's a look at some of the top Wall Street stories for medical device companies this week: Medtronic updates on $43B Covidien deal financing; Boston Scientific, Bard CEOs cool on consolidation; Nevro sets range for IPO of up to $106m; Alere to sell Alere Health unit to Optum for $600m; Skyline Medical conducts 1-for-75 reverse stock split
Abiomed says it's come to an agreement with the FDA on an indication for its flagship Impella 2.5 heart pump, and now expects to win pre-market approval early next year without a hearing before an FDA advisory panel.
Medtronic and Covidien say their pending, $43 billion merger is expected to close in early 2015.
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.
For people with disabilities, medical devices can offer a vital and potentially life-changing option. Take, for example, a patient who has had his arms amputated. Medications can treat phantom pain, but they can't help that patient pick up a glass of water. But devices can – and do.
In recent months, FDA has reviewed a number of noteworthy products for people with disabilities. And it has approved, cleared or allowed manufacturers to market several new devices.
Aethlon Medical plans to make its Hemopurifier blood-filtration device available to U.S. healthcare providers for the treatment of Ebola under the FDA's compassionate use provision.
Creganna-Tactx Medical pays an unspecified amount to acquire Precision Wire Components and rebrands as Creganna Medical.
Irish medical device outsourcer Creganna-Tactx Medical said today that it agreed to acquire Precision Wire Components LLC for an unspecified amount, saying it will re-brand as Creganna Medical.
Google is reportedly developing a pill designed to use nanoparticles to detect cancer and other conditions.
Google (NSDQ:GOOG) is reportedly working on a pill designed to use magnetized nanoparticles to detect cancer and other conditions.
Abbott pays $250 million plus milestones for Topera Medical and its cardiac arrhythmia mapping technology and inks a deal to acquire Advanced Cardiac Therapeutics and its ablation catheter.
Prices for the 10 most popular medical devices declined by an average of 5% in August, compared with the same period last year, according to the Modern Healthcare / ECRI Institute technology price index.
Prices for the 10 most sought-after medical devices slid nearly 5% in August, compared with the same month last yera, according to the Modern Healthcare / ECRI Institute technology price index.
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.
By Tom Ulrich
The FDA sends a warning letter to Cook Medical, saying inspections last summer turned up problems at a Bloomington, Ind., plant that makes vascular devices.
The FDA today released a warning letter it sent to Cook Medical last month, flagging problems found during inspections of a Bloomington, Ind., plant last summer.
Alere says it plans to sell its health-management unit to Optum for $600 million in cash in order to focus on its core rapid diagnostics business.
Alere agreed to sell Alere Health, its health-management unit, to health-services provider Optum for $600 million in cash in order to focus on its core rapid diagnostics business.
Ex-Google commerce chief Stephanie Tilenius launches Vida, an app designed to help patients manage chronic diseases.
(Reuters) - Having difficulty managing chronic disease? Now there's an app for that.
QT Vascular acquires the Java technology for aortic valvuloplasty in transcatheter aortic valve implants for an undisclosed amount.
QT Vascular said it acquired a new technology platform created by an undisclosed developer in Israel called Java that it plans to develop as an aortic valvuloplasty balloon for transcatheter aortic valve implants.
Zoll Medical says it's agreed to acquire Impact Instrumentation and its line of respiratory care devices for an unspecified amount.
Zoll Medical today said it agreed to acquire Impact Instrumentation, which makes respiratory care devices, for an unspecified amount.
West Caldwell, N.J.-based Impact makes portable and automatic emergency ventilators, portable and onboard aspirators, custom mounting systems, and specialized testing systems, according to a press release.
Here's a look at some of the top regulatory stories for medical device companies this week: Boston Scientific wins CE Mark, FDA nod for spinal surgical leads; ReFlow has new Wingman35 in U.S. market; Auditors: FDA needs to boost cybersecurity; Life Spine creates Centric Medical ankle & foot unit
Skyline Medical conducts a 1-for-75 reverse stock split, reducing the number of outstanding shares to approximately 3 million.
German ophthalmic device maker Implandata Ophthalmic Products raises €3 million in its latest round of funding and establishes a Delaware-based subsidiary to help launch its lead product in the U.S.
German ophthalmic device-maker Implandata Ophthalmic Products said it raised €3 million (about $3.8 million) in its latest funding round and established a Delaware-based subsidiary to help launch its lead product in the U.S.
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.
By Joshua Feblowitz
Wright Medical says it plans to acquire Tornier for $3.3 billion and announces an approvable letter from the FDA for its Augment bone graft.
Hill-Rom looks to the energy industry for its new CEO, Steven Strobel, lured from retail energy services company BlueStar Energy.
Hill-Rom Holdings (NYSE:HRC) said it looked to the energy industry to replace James Saccaro as CFO, naming BlueStar Energy's former CFO Steven Strobel to the position.
Sequent Medical CEO Tom Wilder tells MassDevice.com why his company's MicroBraid technology is a key differentiator in its Web device for treating brain aneurysms and, potentially, other conditions.
Infraredx inks a deal with HealthTrust to provide its TVC coronary imaging system to some 1,400 acute care facilities.
Infraredx said it inked a deal with HealthTrust Purchasing Group for its TVC imaging system, which uses both near-infrared spectroscopy and intravascular ultrasound to provide images of coronary blood vessels.
Australian physicians use TransMedics' organ care system to preserve 3 donor hearts for transplantation after circulatory death.
Transmedics said surgeons in Australia used its organ care system to preserve and assess a trio of hearts from donors whose organs had stopped beating, before the hearts were successfully transplanted.
Globus Medical acquires Transplant Technologies of Texas, a provider of bone allografts, biomaterials and soft tissue products, for an unspecified amount.
Here's a look at some of the top legal news stories for medical device companies this week: Ex-Boston Scientific engineer accused of stealing balloon catheter secrets; Jury clears DePuy in 1st Pinnacle bellwether trial; U.S. Patent Office denies Medtronic request in Endotach stent case; Jury deliberations begin in first trial over DePuy's Pinnacle hips; Johnson & Johnson's DePuy wins first trial over Pinnacle hips
Valeant Pharmaceuticals says it's ready to up the ante in its hostile takeover bid for Allergan.
The FDA approves St. Jude Medical's TactiCath Quartz force-sensing ablation catheter for treating atrial fibrillation.
Integra LifeSciences says it closed the $60 million buy of a pair of Medtronic's ear, nose & throat instrument lines.
Salesforce is reportedly ramping up to enter the healthcare market in a big way.
Covidien says it plans to divest its vascular therapies business to mollify U.S. anti-trust regulators about its proposed $43 billion merger with Medtronic.
By Michael Colombo
A look at the top 10 politicial action committee donations shows that medtech is betting heavily on a GOP win in the midterm elections.
The medical device industry is betting on a Republican sweep of the U.S. Congress during the 2014 mid term elections, according to a MassDevice.com analysis of donations made by the industry's 10 largest political action committees.
Medtronic issues an update on the debt financing behind its pending $43 billion acquisition of Covidien.
The U.S. attorney for Massachusetts subpoenas Novo Nordisk for documents on its plant in Denmark that makes half the world's supply of insulin.
(Reuters) - Denmark's Novo Nordisk , the world's biggest maker of insulin, has received a U.S. subpoena requesting documents relating to potential manufacturing issues at its Kalundborg plant in Denmark, the company said on Friday.
Here's a look at some of the top legal news stories for medical device companies this week: Sinopsys Surgical sniffs up $8.3m for sinusitis device; ZipLine Medical adds $5.7m to Series C round; Medrobotics taps backers for $20m; Sensory Medical raises $1.4m for Relaxis restless legs treatment; Stealth hypertension startup Sympara Medical raises nearly $6m
EndoStim, which makes an implantable device to treat gastroesophageal reflux disease, reportedly tables its initial public offering due to poor market conditions.
EndoStim, citing poor market conditions, has tabled its initial public offering it hoped would raise nearly $36 million for its neurostimulation device for gastroesophageal reflux disease, according to Renaissance Capital.
EndoStim had planned to put $10 million of the IPO's proceeds into clinical studies and another $14 million to commercialize the system.
In this DeviceTalks preview, we catch up with Masimo CEO Joe Kiani to discuss new challenges facing the company and how medtech can break the cycle of the era of 'good-enough' innovation.
A federal jury in Texas reportedly clears Johnson & Johnson's DePuy Pinnacle hip implant in the 1st bellwether product liability trial over the metal-on-metal device.
Edwards Lifesciences reports 3rd-quarter sales and earnings growth in excess of 20% and raises its outlook for the rest of the year.
Insights and updates from the experts at Pacific Bridge Medical (PBM). PBM's blog provides recent medical device and pharmaceutical business trends and regulatory updates in Asia.
By Ames Gross, President, Pacific Bridge Medical
