The proxy war over control of the board of directors at ConMed gets ugly, with allegations of sexual harassment levied against 1 nominee.
The proxy war over control of the board at ConMed (NSDQ:CNMD) turned ugly this week after serious allegations surfaced against 1 of the medical device company's nominees for director.
Here's a look at some of the top funding stories for medical device companies this week.
Medtronic says it plans to offer $2 billion worth of senior notes
A bill to repeal the medical device tax sponsored by Sen. Orrin Hatch (R-Utah) advances to the Senate Finance Committee.
A bill aiming to repeal the medical device tax sponsored by Sen. Orrin Hatch (R-Utah) advanced to the Senate Finance Committee this month.
The bill was read in and sent to the finance panel Feb. 7. It would strike all references to the 2.3% excise tax on medical devices enacted as part of the Affordable Care Act from the federal tax code.
The FDA's proposed changes to the medical device 510(k) modification review process aim to clarify existing policy rather than change it.
Medical device makers lauded the FDA this week for policy proposals that would leave existing 510(k) modification rules generally intact, rather than pursuing the overhaul proposed 3 years ago.
U.S. healthcare regulators recover a record $4.3 billion in 2013 through initiatives for detecting and taking action against Medicare fraud.
MASSDEVICE ON CALL — Healthcare and Justice Dept. regulators hit a new record high in recovered healthcare dollars, with $4.3 billion returned to federal health programs in 2013.
That's a return of more than $8 for every $1 spent on federal Health Care Fraud and Abuse Control Programs, according to McClatchy DC.
Carlyle Group, the new private equity owner of Ortho-Clinical Diagnostics, the former Johnson & Johnson blood testing unit, named Martin Madaus as CEO.
The Carlyle Group said it tapped Martin Madaus to take over as CEO of the Ortho-Clinical Diagnostics business it's acquiring from Johnson & Johnson (NYSE:JNJ).
Symmetry Medical says it plans to close a plant in Cheltenham, England, this year, meaning job cuts for 40 workers.
Symmetry Medical's (NYSE:SMA) said it plans to close a plant in Cheltenham, England, this year, meaning layoffs for 40 workers there.
The Warsaw, Ind.-based medical device company said the plant makes medical instruments.
A tax reform package from Rep. Dave Camp (R-Mich.) would repeal the 2.3% tax on U.S. sales of medical devices enacted along with the Affordable Care Act.
A comprehensive tax reform plan put together by Rep. Dave Camp (R-Mich.) would do away with the medical device tax contained in Obamacare, but the package appears to be a dead letter in Washington after Republican leaders cast doubt on its chances for a vote this year.
Camp, chairman of the House Ways & Means Committee, said it's high time the U.S. overhauled its tax code, which hasn't seen a major revision since 1986.
HeartWare shares come under pressure after the medical device company reports higher-than-expected losses for the 4th quarter and 2013.
Investors punished HeartWare International (NSDQ:HTWR) today for missing expectations with its 4th-quarter and full-year results, paring some 3% from HTWR shares.
NxStage Medical beats expectations with its 4th-quarter and 2013 results, but investors send shares down anyway.
NxStage Medical (NSDQ:NXTM) shares rose today after the medical device company said it just beat estimates with its results for the 4th quarter and last year.
A pair of New York radiology services providers agree to pay $15.5 million to settle allegations that they billed Medicare for unnecessary or fake imaging services and paid illegal kickbacks to referring physicians.
New York-based Doshi Diagnostic Imaging Services and Diagnostic Imaging Group LLC agreed to pay $15.5 million to settle whistleblower allegations that they colluded to defraud Medicare and paid physicians for referrals.
The Emergo Group Blog provides short updates on quality and regulatory topics that may be of interest to QA/RA professionals in the medical device and IVD industry. No fluff, just straight to the point. We hope you'll enjoy the content.
By Stewart Eisenhart, Emergo Group
FDA medical device chief Dr. Jeffrey Shuren testifies before Congress that the agency is obligated to track down any sources of leaked information on medtech applications, as prominent members of Congress accuse the agency of crossing the line in spying on whistleblowers' computers.
Ocular Therapeutix says it won a reimbursement code for the insertion of its drug-eluting intracanalicular plugs.
Ocular Therapeutix said it landed a reimbursement code for the insertion of the drug-eluting eye plugs it's developing to treat glaucoma.
Bedford, mass.-based Ocular Therapeutix said the American Medical Assn. issued a CPT code "for the insertion of a drug-eluting implant, including punctal dilation and implant removal when performed, into the lacrimal canaliculus."
ConMed accedes to the demands of a major shareholder, appointing a new chairman to replace founder Eugene Corasanti, who will leave the board entirely this year.
ConMed (NSDQ:CNMD) reached a deal with an institutional investor that owns a 6% stake in the medical device company that will see founder Eugene Corasanti step down as chairman, effective immediately.
FDA inspectors rebuke Advanced Medical Research Institute for human clinical trials conducted without approval from an Institutional Review Board, as well as illegal marketing and missing adverse event reports.
FDA regulators had strong words for Advanced Magnetic Research Institute International following an inspection of the electromagnetic therapy center's practices.
LeMaitre Vascular says it plans to lay off about 10% of its workforce, or roughly 30 workers, despite posting record sales during the 4th quarter.
LeMaitre Vascular (NSDQ:LMAT) said it plans to lay off about 10% of its workforce, or about 30 employees, even as it comes off of a record sales performance during the 4th quarter.
European regulators approve Reverse Medical's UNO neurovascular embolization system to obstruct blood flow in the brain.
Reverse Medical secured European CE Mark approval for its UNO neurovascular embolization system, for obstructing blood flow in the blood vessels of the brain. The device also notched initial clinical use for intracranial specification.
RTI Surgical subsidiary Pioneer Surgical Technology renews a supply deal with Zimmer's trauma division.
Carestream Health lands 510(k) clearance from the FDA for its Vue Motion X-ray app for mobile devices made by tech giants Apple and Samsung.
Carestream Health said it landed 510(k) clearance from the FDA for its new Vue Motion mobile app for Apple and Samsung mobile device platforms.
The app gives physicians mobile access to X-ray exams using Apple's iPhone 4 and iPad 2 devices, as well as the Galaxy Note and Galaxy S III devices made by Samsung.
A Mayo Clinic academic clinical team links up with a group of tech entrepreneurs to start provide hospital data management.
A Mayo Clinic team and a group of seasoned technology entrepreneurs launched a new company called Ambient Clinical Analytics, aiming to provide real-time data and analyses for intensive care units and operating rooms.
Cybersecurity researchers report that many U.S. hospitals and their medical devices have been infiltrated by malware and remain infected as hacks go undetected.
Unsecured medical devices represent an increasing risk for hospitals, with radiology imaging systems in particular named as a prominent "attack surface" for digital attackers.
New laws proposed by India healthcare regulators would for the 1st time treat medical devices as a category distinct from pharmaceuticals.
MASSDEVICE ON CALL — U.S. medical device makers lauded India's healthcare officials for progress on a bill that would for the 1st time separate medical device regulation from pharmaceuticals.
The bill was introduced last year and then referred to a standing committee. The committee's recommendations were tabled in December and are now under review by India's union health ministry, according to the Indo-Asian News Service.
The Emergo Group Blog provides short updates on quality and regulatory topics that may be of interest to QA/RA professionals in the medical device and IVD industry. No fluff, just straight to the point. We hope you'll enjoy the content.
By Stewart Eisenhart, Emergo Group
Officials at Volcano discuss the company's Q4 2013 earnings. The company reported losses of $20.5 million, or 38¢ per share, on sales of $103.3 million for the 3 months ended December 31, for swing to losses on sales growth of 0.8%.
Capitol Hill veteran Clayton Hall joins the Medical Device Manufacturers Assn. as vice president of government affairs and the Medical Imaging & Technology Alliance names Erin Doty Georges director of federal & state government relations.
The Medical Device Manufacturers Assn. and the Medical Imaging Technology Alliance tapped a pair of Capitol Hill veterans to lead their government affairs departments.
Clayton Hall, a former chief of staff for 3 representatives with 12 years on The Hill, was named vice president of government affairs at MDMA, the association said.
Rep. Erik Paulsen (R-Minn.) urges President Barack Obama ahead of Minnesota visit to take mercy on medical device makers, which have faced layoffs and R&D cuts in the wake of the 2.3% medical device tax.
President Barack Obama is slated next month to make a visit to one of the medical device industry's primary hubs in Minnesota, and medtech advocates are hoping to use the occasion to emphasize efforts to repeal a 2.3% sales tax that hit the industry last year.
Wright Medical says it's not optimistic about an FDA dispute resolution panel this May on its Augment biologic bone graft.
Wright Medical (NSDQ:WMGI) said it's not optimistic about an FDA dispute resolution panel on its Augment biologic bone graft product, now slated for May, and would quickly move to cut costs at the BioMimetic Therapeutics subsidiary it bought back in 2012.
Officials at DexCom discuss the company's Q4 2013 earnings. The company reported losses of $2.6 million, or 4¢ per share, on sales of $51.3 million for the 3 months ended December 31, for losses narrowed by 70% on sales growth of 62%.
Medtech recalls were down 20% in the 4th quarter of 2013, but they affected groups across greater geographic regions, analysts said.
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Medical device companies closed 2013 with what seemed like good news, reporting the fewest number of recalls in 7 quarters, but that figure may be "deceiving," analysts said.
Pursuit Vascular comes within shouting distance of a $1.6 million funding goal for its ClearGuard device for reducing catheter infections.
Pursuit Vascular is close to reaching a $1.6 million funding goal, having raised $1.57 million, according to a regulatory filing.
Minneapolis-based Pursuit Vascular is devleoping technology for reducing catheter infections, including the ClearGuard platform that's designed to cut infections associated with hemodialysis catheters.
A federal appeals court denies Otto Bock Healthcare's bid to keep prosthetic devices made by Össur off the U.S. market while their patent infringement lawsuit proceeds.
A $107 million goodwill write-off results in nearly tripled losses in the 4th quarter for DJO Global's public reporting subsidiary DJO Finance.
DJO Global's public reporting subsidiary posted a major increase in losses for its 4th quarter, driven primarily by a $106.6 million goodwill write-down that nearly tripled the company's red ink.
DJO posted a 180% increase in losses on an 8% increase on sales during the quarter, as well as a 71% increase in losses and a 4% increase in sales for fiscal 2013.
Advanced Medical Isotope Corp. considers pursuing regulatory down-classification for its brachytherapy cancer product.
Washington-based Advanced Medical Isotope Corp. is evaluating its options for U.S. market approval of its proprietary brachytherapy cancer product, the company announced.
Evena Medical says it pulled in $5 million in a Series B it hopes will eventually reach $15 million and announced a distribution deal in the Middle East for its Eyes-On vascular imaging glasses.
Evena Medical said it landed $5 million in a Series B funding round and inked a distribution deal in the Middle East and North Africa.
Silicon Valley-based Evena said it hopes the financing round will eventually reach $15 million. This tranche of the round comes from its new, unnamed distribution partner in 15 Middle Eastern and North African countries.
Acid reflux treatment device maker EndoGastric Solutions admits no wrongdoing in agreeing to pay $5.3 million to settle allegations of Medicare fraud and illegal kickbacks.
California medical device maker EndoGastric Solutions agreed this month to pay $5.3 million plus interest to settle Justice Dept. allegations that the company engaged in Medicare fraud and illegal kickbacks to promote its EsophyX acid reflux disease treatment device.
Philips Healthcare's Respironics subsidiary recalls 600 of its Trilogy ventilators due to a defective power management board component.
Respironics, a subsidiary of technology giant Philips (NYSE:PHG), recalled some 600 of its Trilogy ventilators.
The recall, over a glitch in the ventilator's power management board, covers Trilogy models 100, 200, and 202, according to a press release.
Westby G. Fisher, MD, FACC is a board certified internist, cardiologist, and cardiac electrophysiologist practicing at NorthShore University HealthSystem in Evanston, IL, USA and is a Clinical Associate Professor of Medicine at University of Chicago's Pritzker School of Medicine.
AliveCor says it plans to integrate its smartphone heart monitor with its 1st electronic medical record, tapping Practice Fusion's free, ciould-based EMR system.
AliveCor said it plans to integrate its smartphone heart monitor with an electronic medical record platform for the 1st time.
Some 650 lawsuits filed in an Oklahoma court over its pelvic mesh products ought to be treated as a mass action in federal court, Johnson & Johnson subsidiary Ethicon argued this week.
The plaintiffs in some 650 product liability lawsuits filed in an Oklahoma court over Ethicon's pelvic mesh products are improperly looking to exclude them from mass action status, the Johnson & Johnson (NYSE:JNJ) subsidiary argued this week in a federal appeals court.
Johnson & Johnson subsidiary Cordis Corp. wins European CE Mark approval for its Renlane renal denervation system for treating patients with resistant hypertension.
The MedTech Idol venture capital competition, in which the audience chooses the winning medical device startup, heads to Dublin in April.
MedTech Idol is expanding its reach across the pond, opening up a competition for European medical device makers.
The contest, launched stateside last year, is produced by venture capital shop RCT Ventures. The competition exposes start-ups to a group of highly focused medical device investors, allowing the audience to choose the winner.
Seno Medical says investors converted $26 million worth of notes into stock, raising another $4.7 million in a funding round it hopes will top out at $39 million.
Seno Medical said some of its investors converted notes into nearly $27 million worth of stock in the breast cancer detection device maker.
In a regulatory filing, San Antonio-based Seno said it pulled in $30.4 million of a hoped-for $39 million from 49 unnamed backers, with $25.7 million consisting of notes converted into Series C preferred stock.
Paradigm Spine inks a $75 million credit deal with PDL BioPharma it plans to use to refinance its existing credit and boost its U.S. commercial efforts.
Paradigm Spine said it inked a $75 million credit agreement with PDL BioPharma.
Paradigm Spine, which makes spinal implants, said it will take the 1st $50 million in at closing, with another $25 million in milestone-based payments on the table.
Cordis Corp. will have TriReme Medical distribute its Chocolate PTA balloon catheter, expanding the company's portfolio.
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Cordis Corp., a Johnson & Johnson (NYSE:JNJ) subsidiary, said it inked an exclusive deal to distribute TriReme Medical's Chocolate PTA balloon catheter.
The Chocolate PTA device is designed to treat peripheral artery disease
A pair of studies released at this week's American Academy of Neurology meeting highlight smartphone apps that aim to help doctors manage care for acute stroke patients and the public identify epileptic seizures.
MASSDEVICE ON CALL — Neurologists this week unveiled studies for a pair of smartphone apps that could help patients suffering seizures or strokes.
The FDA's Anesthesiology & Respiratory Therapy Devices Panel unanimously recommends Inspire Medical's Inspire II Upper Airway Stimulator for U.S. approval.
An expert panel of FDA advisors voted today to recommend approval for Inspire Medical's sleep apnea implant, the Inspire II Upper Airway Stimulator, according to The Gray Sheet.
The Massachusetts Life Sciences Center offers $25 million in tax incentives to local life sciences companies, about 1/3 of which went to medical device makers.
The Massachusetts Life Sciences Center handed out $25 million in tax breaks to local companies, with 6 medical device makers taking $7.8 million of the total pot.
The Philadelphia Court of Common Pleas establishes a mass tort for all pelvic mesh lawsuits filed in its jurisdiction.
A Pennsylvania state judge ordered the creation of a mass tort this week to collect product liability lawsuits filed over pelvic mesh products against some of the largest names in medical devices.
Judge Arnold New, director of the Complex Litigation Center at the Philadelphia Court of Common Pleas, ordered Feb. 11 that "all currently filed pelvic mesh matters shall be transferred to the Complex Litigation Center Pelvic Mesh Mass Tort Program" for coordination, according to court documents.
W.L. Gore's newly approved drug-coated Viabahn stent graft beat the current standard of care in treating patients with stenoses or thrombotic occlusions, according to the REVISE clinical study findings.
Arizona medical device maker W.L. Gore & Assoc. teased positive results from its REVISE clinical trial, promising to release additional findings during the American Society of Diagnostic & Interventional Nephrology meeting in Phoenix this week.
Titan Medical sells more than 9.1 million shares in an over-allotted offering that brought in nearly $12.8 million to support development and commercialization efforts.
Interventional Spine says the FDA expanded the 510(k) clearance for its Opticage spine implant.
Interventional Spine said it secured expanded 510(k) clearance from the FDA for its Opticage spine implant
The Irvine, Calif.-based company makes implants used in spine surgeries, with a focus on osteoporosis-afflicted bones. expandable interbody fusion device.
Stryker Corp. expands its sports medicine business with the acquisition of Pivot Medical and its hip arthroplasty system.
