A group of creditors are looking to force OPK Biotech, the holding company created by a former Russian oligarch to buy out defunct Biopure's assets, into its own bankruptcy proceeding.
Creditors hoping to collect $1.4 billion from OPK Biotech are seeking to force the Biopure Corp. successor into Chapter 7 bankruptcy.
Without naming names, Forbes contributor and Permanente Medical Group CEO Dr. Robert Pearl calls out makers of robot-assisted surgical systems for their role in 'increasing prices for products that don't add much value.'
Surgical robots are taking one for the team, becoming the latest poster child for over-priced U.S. healthcare.
The Translational Research Institute said the FDA cleared its ND infusion catheter for "infusion of physician-specified fluids" into the coronary vasculature. Check out this video from TRI describing how it works.
California medtech startup Acutus Medical lands European CE Mark approval for its real-time 3D imaging and mapping 'Katheter.'
European regulators approved Acutus Medical's flagship 'Katheter' device, a diagnostic catheter for real-time 3D imaging and mapping of the heart.
The Katheter is just a part of Acutus Medical's larger stand-alone system, the company said. The device contains 48 ultrasound crystals and electrodes that capture both the geometry of the heart and its electrical activity.
The FDA's medtech arm is looking for volunteers to pilot its electronic 510(k) application submission software, starting with cardiovascular devices/diagnostics and peripheral intervention devices.
U.S. medical device regulators are looking for volunteers to test out a software-based version of its 510(k) submission program, an alternative to submissions that traditionally require paper copies or compact discs.
The new "CDRH 510(k) eSubmissions Pilot Program" will guide users through creating and submitting a 510(k) medical device review application electronically. The FDA is hoping a few guinea pigs will volunteer to run the course and provide feedback.
Roger Pontz, 1 of the first recipients of Second Sight Medical's Argus II 'bionic eye,' tells MassDevice.com about how it's changed his life.
A version of this story was originally posted on BetaBoston.com
In his hometown of Reed City, Mich., Roger Pontz is a dishwasher in a bowling alley bar. But in medical circles, he's a pioneering a new frontier.
Anthem Blue Cross & Blue Shield will cover Edwards Lifesciences' Sapien heart valve for extreme risk patients, leaving high-risk patients (and Medtronic's CoreValve implant) out in the cold.
California orthopedics company SI-Bone plans to boost its workforce, expand outside the U.S. and make progress on its clinical trials after adding $33 million to its coffers.
San Jose, Calif.-based SI-Bone has big plans for its newly raised $33 million, saying it'll use the new funds to add additional resources and chase regulatory approvals overseas for its iFuse bone fixation system.
Financing came from new investors Orbimed and Novo A/S, as well as from existing funders Skyline Ventures and Montreux Equity Partners, SI-Bone reported.
California molecular diagnostics maker CardioDx takes another swing at an initial public offering and adds a few members to its leadership team.
More than 5 months after ditching efforts to open on public markets, California-based CardioDx is ready to take another swing at an initial public offering.
In regulatory documents filed this week the molecular diagnostics maker assigned new underwriters, named a couple of new executives and added 2 members to its board of directors. CardioDx has not yet revealed exact timing or terms for the revived IPO.
Here's a look at some of the top personnel stories for medical device companies this week.
FDA regulators consider ramping up regulatory oversight of pelvic organ prolapse devices amid the ongoing public din over the dangers to women.
The FDA today issued a pair of proposed orders that would increase regulatory oversight of controversial pelvic mesh products, responding to a long-running public uproar about the implants' potential for harm to women.
Stryker says it's planning to refinance its debt with a senior notes flotation worth $1 billion.
Stryker (NYSE:SYK) said it's planning to float $1 billion worth of senior notes as it refinances its debt load.
The Kalamazoo, Mich.-based medical device company said it's pricing 2 sets of senior unsecured notes: $600 million, at 3.38% annually, due in May 2024; and $400 million, at 4.38%, due in May 2044.
Boston Scientific beat expectations with its 1st-quarter earnings, but missed the sales mark, sending shares down this morning despite a boosted earnings outlook for the rest of the year.
Embattled Intuitive Surgical touts results from a pair of studies finding robot-assisted lung surgery outcomes equal to or better than common minimally invasive procedures.
Here's a look at some of the top regulatory stories for medical device companies this week.
Orthofix names David Ziegler as interim CFO after Emily Buxton's resignation and names CareFusion CFO James Hinrichs to its board of directors.
FDA regulators warn Indiana's Dr. Pattanam Srinivasan for conducting unapproved clinical trials in which he is the sponsor, investigator and head of the independent review board.
FDA regulators this month unveiled a series of warning letters issued to Dr. Pattanam Srinivasan, saying that the doctor authorized, sponsored and oversaw unapproved human experiments at the Indiana-based Advanced Interventional Pain Center.
A federal appeals court upholds the U.S. Patent & Trademark Office's decision to deny St. Jude Medical's bid for a review of a fractional flow reserve patent.
Swiss medtech maker Sequana Medical closes a $26.2 million (CHF 23 million) Series C financing round in support of its alfapump implantable bladder pump for patients with liver disease.
Switzerland-based medtech company Sequana Medical has big plans for its newly-closed $26.2 million (CHF 23 million) Series C financing round, hoping to use the funds to widen its global sales and begin penetrating the U.S. market.
A 2-year study at a chain of Midwest hospitals finds everything from defibrillators to electronic patient records far too easy to hack into and manipulate.
Newly unveiled findings from a 2-year audit of a chain of Midwest hospitals corroborated what many in cybersecurity have long said about medical devices: they are too often woefully lacking in digital defenses.
FDA regulators cleared Aurora Spine's ZIP ULTRA spinal fusion system in new sizes as well as the company's sterile-packed ZIP MIS device.
California spinal devices maker Aurora Spine touted a pair of FDA wins, landing clearance for additional sizes of its ZIP ULTRA spinal fusion system and additional clearance for the company's ZIP MIS.
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 only time most of us ever look at an insurance claim is after a hospital or doctor visit, when we get a claim summary from our carrier. And then as far as we know, it gets filed away, never again to see the light of day.
But there's a lot to be learned from these claims data.
Here's a look at some of the top legal news stories for medical device companies this week.
Lombard Medical's shares lose 9% during their 1st day trading on the Nasdaq stock exchange, closing $1 lower than they opened.
The increasing transition to electronic medical records paired with their alluring black market value puts medical devices and other hospital technology in the cross-hairs for malicious hackers, according to an FBI report.
Medical devices and other hospital and healthcare systems need some serious security upgrades to weather the coming onslaught of malicious hacking, according to the FBI's Cyber Division.
With an impending deadline to shift to electronic medical records, which fetch a high price on the black market, healthcare systems are an increasingly alluring target for cyber-criminals.
Officials at Edwards Lifesciences discuss the company's Q1 2014 earnings. The company reported profits of $60.3 million, or 56¢ per share, on sales of $522.4 million for the 3 months ended March 31, for profit loss of 58.1% on sales growth of 5.2%.
Luna Innovations receives $6 million in the 2nd tranche of its deal with Intuitive Surgical, which acquired Luna's shape-sensing technology for integration with its da Vinci surgical robots.
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.
Here's a look at some of the top funding stories for medical device companies this week.
Valeant Pharmaceuticals' $47 billion offer for aesthetics maker Allergan is nothing to get excited about, says top-20 shareholder Polen Capital Management.
The hacker group Anonymous calls for internet activists to bombard Boston Children's Hospital with a flood of internet traffic to disrupt its online services, the same type of attack that has been known to knock out medical devices.
Officials at Boston Children's Hospital confirmed this week that they'd weathered some digital mayhem affecting the clinic's web services in the weeks following threats from the online hacker group Anonymous.
The hospital's website has faced some outages, but it's not clear that the disruptions are related to Anonymous and the group's public demands regarding a pediatric patient made a ward of the state, hospital officials said. The BCH website was intermittently in and out of service during the writing of this article.
The orthopedics industry continues to consolidate with a string of mergers and acquisitions leading up to Zimmer's landscape-altering $13.35 billion acquisition of Biomet.
Wall Street rallies for Zimmer as the orthopedics giant posts top and bottom line gains and announces a mega-offer for Biomet.
Warsaw, Ind.-based orthopedic heavyweights Zimmer and Biomet agree to a merger valued at $13.35 billion.
Baxano Surgical puts a ribbon on a private placement funding round after raising $10 million from unnamed investors.
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
A new proposal by the US Food and Drug Administration would allow faster market authorization for some high-risk medical devices targeting diseases that cannot be treated by current approved technologies.
Here's a look at some of the top Wall Street stories for medical device companies this week.
New Hampshire senate candidate Scott Brown (R) returns to the medtech tax repeal fight in his new campaign, calling the levy a "money grab to fund Obamacare."
MASSDEVICE ON CALL — Returning senate hopeful Scott Brown (R-N.H.) renewed his once-fervent call for repeal of the medical device tax, telling reporters during a tour of Gamma Medica that the levy is "just a money grab to fund Obamacare."
Officials at Stryker discuss the company's Q1 2014 earnings. The company reported profits of $70 million, or 18¢ per share, on sales of $2.31 billion for the 3 months ended March 31, for profit loss of 77% on sales growth of 5.3%.
Patient monitoring systems maker Sotera Wireless is looking for another $33.2 million to close a $53.9 million fundraising round.
California-based Sotera Wireless is looking to raise $53.9 million in an ongoing funding round, with about $20.7 million raised as of Monday, regulatory filings show.
U.S. healthcare regulators will meet tomorrow to consider banning the use of electrical shocking devices used in behavior modification.
The FDA's neurological devices panel will meet tomorrow to decide the fate of aversive electrical stimulation, devices that generate electrical shocks used by care providers in order to deter unwanted behavior.
We're in the middle of a revolution in prosthetics, with true bionic integration just over the horizon. But a hidebound Medicare could prevent thousands of amputees from receiving the cutting-edge - and costly - devices.
A version of this story was originally posted on BetaBoston.com
Boston Scientific launches a clinical trial for its Acuity X4 pacemaker and Reliance 4-Front defibrillator leads, ahead of its bid for U.S. FDA approval of the devices.
keys: boston scientific, bsx, acuity x4, reliance 4-front
Nearly 800 employees of the University of Pittsburgh Medical Center are victims of tax fraud after a data breach that exposed their confidential information.
MASSDEVICE ON CALL — Some 788 employees of the University of Pittsburgh Medical Center were the victims of tax fraud after a data breach exposed confidential data for as many as 27,000 workers, the Pittsburgh Post-Gazette reported.
The breach, 1st discovered in February, came after number of employees began reporting identity theft. The ID thefts allowed the fraudsters to file fraudulent tax returns under the employees' names and make off with the resultant refunds, according to the newspaper.
Intuitive Surgical sees shares slump in after-hours trading after posting dreary sales and earnings numbers for the 1st quarter of 2014.
Intuitive Surgical (NSDQ:ISRG) said sales dropped nearly 24% during the first 3 months of 2014, missing analysts' estimates and sending shares down 4% in after-hours trading.
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: Dr. Stephen Ostroff
"I hope no one ever needs these products," isn't something you hear too often, particularly from those developing drugs, biologics, or devices. That point of view—and a universal desire to protect the American public—is what sets biodefense professionals apart.
The FDA proposes an expedited pre-market approval program for high-risk medical devices that address unmet needs.
The FDA today proposed a new regulatory option for high-risk medical devices that address unmet needs, aiming to speed access to the devices for patients.
K2M says its forthcoming initial public offering could garner as much as $183 million, if its underwriters exercise a 1.3 million-share over-allotment.
K2M Group Holdings, the largest privately held spinal implant maker, said today that its forthcoming initial public offering could be worth up to $183 million.
K2M announced its plans for a U.S. IPO early this year, saying in March that the launch could be worth $100 million.
Medline Industries acquires spinal surgery technologies from Amendia, with few details made public about the grab.
Illinois-based Medline Industries acquired key spine surgery technologies from Georgia-based Amendia, the companies announced this month.
Medline nabbed Amendia's anterior cervical fusion distraction pin business, part of a market that Medline expects to grow more than 8% annually. The technologies are used in surgeries for removing problem disks in the neck area of the spine.
Ulthera, which makes an ultrasound device designed to lift lax tissue on the neck and under the chin, registers for an initial public offering worth up to $86 million.
Ulthera filed for a U.S. initial public offering yesterday, saying it hopes to raise as much as $86 million when it debuts on the NASDAQ stock exchange.
Mesa, Ariz.-based Ulthera makes an ultrasound device, which is designed to use the body's natural healing process to non-invasively lift and tighten loose skin on the neck and under the chin.
Ulthera, which makes an ultrasound device designed to lift lax tissue on the neck and under the chin, registers for an initial public offering worth up to $86 million.
Ulthera filed for a U.S. initial public offering yesterday, saying it hopes to raise as much as $86 million when it debuts on the NASDAQ stock exchange.
Mesa, Ariz.-based Ulthera makes an ultrasound device, which is designed to use the body's natural healing process to non-invasively lift and tighten loose skin on the neck and under the chin.
