Teva Pharmaceutical Industries has been taking a deeper dive into med tech this past year, teaming up with industry heavyweight Royal Philips to open a new med tech incubator in Israel. Now the Israeli pharma is forging ahead with another tech initiative, teaming up with University College London for a brain-imaging study to uncover biomarkers for neurodegenerative disease.
Crossover investor Deerfield Management has joined the syndicate of Fractyl Laboratories with a $17 million addition to a Series C financing to bring it up to a total of $57 million. The startup will use the cash to continue backing clinical testing of its Revita Duodenal Mucosal Resurfacing System, which has already started an international multicenter trial and is slated to begin randomized studies in 2016.
Torax Medical's Linx Reflux Management System to treat gastroesophageal reflux disease will have its own Category 1 Procedural Terminology Code next year, paving the way for enhanced public and private reimbursement.
Dx Digest: Invitae builds out cancer and epilepsy testing menus; Illumina gets in on autism research
Welcome to Dx Digest, where FierceMedicalDevices highlights the highs and sometimes lows of the past week in the diagnostics industry. Invitae expanded its hereditary cancer and epilepsy test menu; sequencing giant Illumina announced that it would join forces with the Hartwell Foundation's Hartwell Autism Research and Technology Initiative to build the largest shared genomic database for autism; and Thermo Fisher Scientific gained more traction in the companion diagnostics realm.
Reimbursement for sacroiliac joint fusion as a treatment for some kinds of lower back pain is becoming more common after it gained a reimbursement code at the start of this year, despite the procedure remaining somewhat controversial.
Google Glass flopped as a consumer product, though the company has had some success selling it to businesses, including some devicemakers.
Healthcare IT outfit Molecular Health raked in €25 million ($26.6 million) in financing to spur commercialization for its healthcare informatics platform, giving the company a boost as it charges ahead with product development and expands its global footprint.
Medtronic just announced the acquisition of Scotland's Aircraft Medical, a maker of video laryngoscopes to facilitate successful intubation of breathing tubes into the trachea, for $110 million in cash.
The effective diagnosis and treatment of cancer has remained a largely First World problem so far. But someday, perhaps sooner rather than later, that's expected to no longer be the case. A coalition has created a global initiative to improve access to some of the most underserved populations in sub-Saharan Africa and Haiti.
The FDA is alerting the public that rare cases of underactive thyroid were reported in babies who were given iodine-containing contrast agents for X-rays and other medical imaging procedures.
The Centers for Medicare & Medicaid Services is revamping its payment model for hip and knee replacement by tying payments (or penalties) to patient recovery. Its latest foray into bundled payments is part of a broader attempt to tie 90% of payments to incentive programs by 2018, as the agency shifts away from the fee-for-service model.
Newly emerging med tech players large and small seem more apt to put women in the most plum executive spots--at least that's what our 2015 review of the top women in med tech anecdotally turned up.
Registry data shows that more than 10% of TAVR recipients are being treated off-label, meaning they do not meet the FDA's recommended criteria for use.
Medtronic touted four-year global registry data that's supportive of its Endurant stent graft system for endovascular abdominal aortic aneurysm repair, which it says has global market share of nearly 50%.
The FDA is calling for more oversight of lab-developed tests (LDTs) in the wake of a congressional hearing about the agency's ability to regulate the products, pointing to a new internal report that says certain LDTs "may have caused or have caused" harm to patients by producing incorrect results.
A few weeks ago, minimally invasive surgical startup SI-Bone announced that it had nabbed an expanded indication for its iFuse Implant System from the FDA. Now, the company has gained a $39.2 million credit facility from Oxford Finance and Silicon Valley Bank for $39.2 million to help market iFuse.
Medtronic has launched the first app-based remote monitoring for implantable pacemakers. Remote monitoring of pacemakers has been the standard of care, but this next-gen version goes beyond a dedicated device to do so.
As drug-resistant superbug infections continue to rise, diagnostics companies are rolling out rapid, point-of-care devices that can quickly identify infectious bacteria and potentially cut down on the need for unnecessary antibiotics, cashing in on a growing market for the tools.
A study presented at the annual meeting of the American Academy of Ophthalmology found that programmable electronic glasses help improve vision in children.
The FDA just publicized the voluntary Class 1 recall of Boston Scientific's RotaWire Elite and wireClip Torquer Guidewire and Guidewire Manipulation Device because of complaints of wire fracture.