The medical device tax in back in effect

The ringing in of the new year also rang in the return of the medical device tax, a 2.3% levy on medtech sales that went back into effect after a two-year pause.

The U.S. Congress closed out 2017 without taking action to delay or repeal the medtech tax, despite broad support from both sides of the aisle. Before the holiday recess, House Ways & Means Committee Chairman Kevin Brady (R-Texas) said repealing the medical device tax and others contained in Obamacare would have to wait until early this year.

Late last year Brady and Reps. Erik Paulsen (R-Minn.) and Jackie Walorski (R-Ind.) introduced a bill, H.R. 4617, that would suspend the tax for five years. Later the so-called “Problem Solvers Caucus” in the House filed a bill to amend Obamacare, H.R. 4695, containing a series of amendments to the Affordable Care Act including outright repeal of the medical device tax retroactive to Dec. 31, 2017.

There are at least six other bills in both the House and Senate that would affect the tax, according to Congress.gov, mainly aiming to amend Obamacare. The provisions in a pair of house bills, H.R. 184 and H.R. 1628, include repeal of the tax retroactive to Dec. 31, 2016, and Dec. 31, 2017, respectively; another House proposal, H.R. 1436, would repeal the tax but does not specify a date. And H.R. 286 would exempt emergency medical devices used by first responders.

In the Senate, S. 108 would enact an outright repeal retroactive to the end of last year. Another measure out of the Upper Chamber, S. 554, includes repealing the tax in a laundry list of ACA amendments.

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Masimo wins CE Mark for RD Rainbow Lite SET sensors

Masimo (NSDQ:MASI) said today it won CE Mark approval in the European Union for its RD Rainbow Lite SET sensors designed to monitor the company’s proprietary Masimo oxygen reserve index and RPVi.

The Irvine, Calif.-based company said the rainbow Lite sensors use twice as many wavelengths of light as the company’s SET sensors, enabling ORi and RPVi monitoring along with SET measure-through motion and low perfusion pulse oximetry. ORi is designed to examine a patient’s oxygen reserve in the moderate hyperoxic range, the company said.

Masimo’s RPVi is a multi-wavelength version of the traditional Pleth variability index, and is designed to provide assessment of changes in fluid volume compared to PVi5.

“Rainbow Lite sensors allow clinicians, who depend on powerful SET pulse oximetry technology, to augment their patient monitoring with ORi and newly introduced RPVi. Given the positive reception of ORi in available markets, and feedback from clinicians who see great value in the benefits of ORi monitoring, we are excited to make ORi and RPVi accessible via the cost-effective solution represented by RD rainbow Lite SET. Hospitals that standardize on RD rainbow Lite SET will pay only nominally more per sensor than for SET,” founder & CEO Joe Kiani said in a prepared statement.

With the new clearance, the company’s RD family of sensors are available in three levels of capability, including the RD Set, RD Rainbow Lite SET and RD Rainbow SET.

Last November, Masimo said it won FDA clearance for its NomoLine capnography sampling lines.

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Pear Therapeutics raises $50m for digital substance use disorder therapies

Pear Therapeutics said today that it closed a $50 million Series B round to help commercialize its prescription digital substance abuse therapies. Temasek led the round and was joined by 5AM Ventures, Jazz Venture Partners, Novartis (NYSE:NVS) and others.

In September, the company’s reSET therapy became the first prescription digital therapeutic approved by the FDA. One month later, it’s reSET-O therapy, designed as an adjunct to pharmacotherapy for people with opioid use disorder, won expedited access pathway designation from the FDA.

Get the full story at our sister site, Drug Delivery Business News.

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Si-Bone touts BCBS SI joint fusion operation assessment rating upgrade

Si-Bone today touted that the Blue Cross Blue Shield Association assigned triangular implants for SI joint fusion, including the company’s iFuse implant, as a “moderate” quality evidence recommendation after an extensive review of safety and effectiveness data on the devices and procedures.

The “moderate” grade is the second highest on BCBSA’s four-tier rating system, according to San Jose, Calif.-based Si-Bone, and requires sufficient clinical evidence to judge health outcomes with the devices.

In the update, the BCBSA states that evidence is sufficient to show that the device, used in individuals with common disorders affecting the sacroiliac joint, produces meaningful improvement in the net health outcome of patients, Si-Bone said.

The company said that the evidence used in the upgraded assessment came exclusively from the use of its triangular iFuse implants.

The update also included assessments which graded treatments with therapeutic corticosteroid injections, radiofrequency ablation or cylindrical threaded implants as insufficient, Si-Bone said.

“There is abundant evidence showing that the sacroiliac joint is a significant contributor to lower back pain and that common types of SI joint dysfunction can be effectively treated with a minimally invasive surgical procedure using the triangular iFuse Implant, which we brought to market in 2009.  That said, the SI joint has been under-diagnosed and under-treated for decades and our philosophy has been to take a high level scientific approach, including well-designed and well-executed clinical studies so that the data from these studies could stand on their own for educational, clinical and patient purposes,” clinical affairs VP Dr. Daniel Cher said in a press release.

Last June, Si-Bone said it won FDA 510(k) clearance for its 3D-printed titanium iFuse-3D implant designed for fusion procedures to treat certain disorders of the sacroiliac joint.

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Abbott wins CE Mark for Alinity h-series hematology system

Abbott (NYSE:ABT) said today it won CE Mark approval in the European Union for its Alinity h-series integrated hematology testing system and that it launched the device in the associated regions.

The newly cleared system features integration of the Alinity hq system with the Alinity hs slide marker and stainer module. The company touts the system as operating 20% faster than other integrated hematology systems.

“Today’s hematology laboratories are challenged to perform more tests while reducing errors and operating costs. With built-in simplicity designed specifically for hematology testing, the Alinity h-series is smaller, faster, and more automated than current systems, incorporating advanced features that allow health care professionals to spend less time managing the process of producing results and more time helping patients,” diagnostics prodcuts exec VP Brian Blaser said in a prepared statement.

Abbott said the Alinity h-series features enhanced workflow to integrate workstations into a single platform, custom scaling and system module integration to meet specific needs and reduced wait time via continuous access.

“The Alinity h-series is designed around feedback and insights specifically gathered from hematology customers. System uptime and results accuracy are two examples of high priority needs for high-volume laboratories. With this in mind, a rigorous reliability growth program was executed for the Alinity h-series systems involving millions of cycle runs to identify potential failure points, which were then re-designed for reliability. The software that assesses the samples uses a learning algorithm that offers a unique approach to classifying blood cells, which will ultimately contribute to greater accuracy of results and reduce the need for manual review,” Abbott hematology R&D divisional VP Wade Bolton said in a press release.

Late last month, Abbot said it is maintaining the worldwide halt on implantations of the Nanostim leadless pacemaker made by its St. Jude Medical subsidiary after reports surfaced of problems with the device’s docking button.

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Inovio lands $23m in collab with ApolloBio for HPV immunotherapy

Inovio Pharmaceuticals (NSDQ:INO) has inked an amended collaboration and licensing deal with ApolloBio for its DNA immunotherapy product designed to treat the pre-cancers caused by human papillomavirus.

The exclusive partnership is limited to China, Hong Kong, Macao and Taiwan, but it could also include the Republic of Korea over the next three years, Inovio reported. In connection with the deal, ApolloBio is slated to pay $23 million upfront and as much as $20 million later, based on certain milestones.

Get the full story at our sister site, Drug Delivery Business News.

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FDA refines least burdensome guidance for medical device oversight

By Stewart Eisenhart, Emergo Group

Medical device regulators at the Food and Drug Administration have updated guidance clarifying what Least Burdensome Provisions mean for US market registrants.

Get the full story here at the Emergo Group’s blog.

The opinions expressed in this blog post are the author’s only and do not necessarily reflect those of MassDevice.com or its employees.

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