Philips acquires pulse oximetry sensor maker Xhale Assurance

Royal Philips (NYSE:PHG) said this week it acquired pulse oximetry sensor maker Xhale Assurance for an undisclosed amount.

Xhale Assurance produces a disposable pulse oximetry sensor designed to be placed on the wing of the nose to monitor heart rate and blood oxygenation under low perfusion conditions, which Amsterdam-based Philips said can be challenging with conventional fingertip sensors.

Philips said that the acquisition will differentiate its existing oxygen saturation monitoring solutions protfolio and allow it to expand into an underserved clinical segment.

“Xhale Assurance’s nasal alar sensor offers exceptional clinical capabilities and strengthens our patient monitoring offering with a next-generation pulse oximetry sensor technology. The sensor technology also offers opportunities to develop measurements of further physiologic parameters. I am excited that this will augment our ability to offer solutions that enhance patient safety, support clinical workflow, improve caregiver efficiency, and help our customers implement value-based healthcare,” Philips monitoring & analytics biz leader Felix Baader said in a press release.

Earlier this week, a report emerged suggesting Philips is looking to cut another 280 jobs from its Andover, Mass.-based facilities.

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Report: Apple is exploring custom health sensor tech

Apple (NSDQ:AAPL) may be looking to develop its own health sensor chip technology, according to a new report from CNBC.

The tech giant posted a job opening in mid July looking for “sensor ASIC architects to develop ASICs for new sensors and sensing systems for future Apple products,” according to the report.

A separate posting from August showed that Apple is looking for someone to “help develop health, wellness, and fitness sensors,” according to CNBC. An additional earlier posting from June mentioned that the company was also looking to continue working with optical sensors, which the company currently uses to measure heart rate.

Currently, Apple uses sensor-connected technology from Broadcom in its Apple Watch product, but may be looking to develop its own chip as a way to protect its IP from third-party developers, according to the report.

The hires don’t absolutely point to new tech, however, and could be related to the company’s existing biosensor technology, according to CNBC.

Apple has not officially commented on the matter.

In June, Reports emerged showing that Apple had submitted a patent application for a wearable blood pressure monitoring cuff.

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Masimo touts study exploring pulse oximetry pre-screening for OSA in children with down syndrome

Masimo (NSDQ:MASI) yesterday released results from a study exploring home pulse oximetry monitoring’s ability to serve as an initial screening method to determine which children with Down syndrome should be recommended to undergo sleep studies to diagnose obstructive sleep apnea.

The Irvine, Calif.-based company said that children with Down syndrome are at high risk of obstructive sleep apnea, which can only be reliably diagnosed using multichannel sleep studies, which are expensive and time-consuming.

A total of 161 children with DS between 0.5 and 6 years old were selected for the trial, 25 of which were separately diagnosed with OSA. Patients were monitored overnight using Masimo’s Radical-7 Pulse CO-Oximeters with sensors placed on the great toe, Masimo said.

Measurements recorded in the trial include total artifact-free time analyzed, mean oxygen saturation, minimum SpO2, 3% oxyhemoglobin desaturation index, Delta 12s index and the number of minutes per hour that SpO2 was below 90%.

Researchers, who were blinded to which subjects had received an OSA diagnosis, found that the use of pulse oximetry monitoring reduce the amount of children with DS who are screened for OSA by approximately half, according to Masimo’s release.

Investigators noted that the findings only applied to Masimo oximeters, and could not be generalized to other devices, and that the use of a retrospective clinical dataset and anonymous data “limits our information on the wider sampling frame, demographic and clinical characteristics of these children.”

Earlier this month, Masimo posted second quarter earnings that beat expectations on Wall Street and raised its guidance for the remaining fiscal year.

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ARTMS’ system may ease cost, shortage of valuable radioisotopes

ARTMS Products (Vancouver, B.C) has won the CE mark for its first-in-class, advanced technology Quantm irradiation system, designed to produce high-value medical imaging isotopes such as technetium-99m (Tc-99m) on medical cyclotrons.

Tc-99m is given to nearly 50,000 Americans every day to diagnose cancer and heart disease. It is used in more than 80% of all nuclear medicine imaging procedures globally, including those for oncology, urology and neurology. The light-emitting isotope is made by bombarding Molybendum-99 (moly-99) with neutrons. The temporary shutdown of two reactors that produced moly-99 led to a global shortage in 2009-10.

The only North American reactor that produced moly-99, in Chalk River, Ontario, produced 40% of the U.S. supply and closed in March. Others are located in Australia, Europe and South Africa. Because of the short half-life and value of moly-99, shipping is costly.  SHINE Medical Technologies is developing a 57,000-square-foot medical isotope manufacturing plant in Janesville, Wisc.

Get the full story on our sister site, Medical Design & Outsourcing.

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5 medtech stories we missed this week: July 6, 2018

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From Zetta getting FDA clearance to Prescient Medical receiving CE Mark approval, here are five medtech stories we missed this week but thought were still worth mentioning.

1. Zetta wins FDA clearance for Zoom MRI software

Zetta announced in a June 25 press release that its MRI software has received FDA 510(k) clearance. The software, known as Zoom, features an algorithm for image quality enhancement and image optimization of short scanning techniques. It works with all MRI models from all major manufacturers, according to the company. Zoom’s algorithm was designed to help MRI imaging departments automatically process MRI imaging techniques.

2. MIM Software, Spectrum Dynamics Medical ink software deal for Veriton scanner

MIM Software and Spectrum Dynamics Medical have partnered to provide MIM-SD advanced visualization and quantitative processing software for the Veriton, according to a June 24 press release. Veriton is a 12 detector CZT multi-organ scanner that has unparalleled sensitivity, image quality and diagnostic accuracy. The detectors are configured for each organ and offers high resolution, lower dose and shorter acquisition times.

3. LumiThera wins CE Mark for LT-300 device for macular degeneration

LumiThera announced in a June 21 press release that it has received CE Mark for its LT-300 device that treats dry advanced macular degeneration. The device is a light delivery system. The CE Mark approval allows the company to commercialize the device in Europe.

4. RTI Surgical launches Fortilink IBF systems

RTI Surgical has launched its Fortilink-TS and -L IBF Systems, according to a June 12 press release. The systems are designed to be used in lumbar interbody fusion procedures at one or two adjoining levels in patients who have degenerative disc disease. Both systems feature the company’s TetraFuse 3D technology that is a 3D printed polymer-based interbody fusion device that uses a nano-rough surface to create more notable trabecular bone ingrowth.

5. Prescient Medical wins CE Mark for CleanCision

Prescient Surgical announced in a June 12 press release that it has received CE Mark approval for its CleanCision system. CleanCision fights and defends against surgical site infection sources. The approval allows for the commercialization of the system throughout Europe. In addition to the CE Mark approval, Prescient Surgical also received ISO 134385:2016 certification for its quality management system.

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Hologic wins CE Mark for Panther Fusion MRSA assay

Hologic (NSDQ:HOLX) said today that its Panther Fusion MRSA assay won CE Mark clearance in the E.U.

The company’s MRSA assay can detect and differentiate between Staphylococcus aureus and methicillin-resistant Staphylococcus aureus in ESwab nasal samples. The test is the latest in Hologic’s portfolio of Panther Fusion and Aptima assays.

With the company’s Panther Fusion system, laboratories can run up to 32 different assays at the same time. MRSA samples can be loaded directly into the Panther Fusion system and labs can expect the test’s results in 2.4 hours, according to Hologic. The Panther Fusion system enables the lab to process up to 500 assays in an 8-hour period, the company added.

Panther Fusion is available as a standalone system or as a module that can attach to existing Panther systems. The module allows labs to run PCR assays in addition to tests based on transcription-mediated amplification, Hologic said.

“The launch of the Panther Fusion MRSA assay demonstrates our commitment to expanding the portfolio of assays available for Panther Fusion, enabling our European customers to deliver a better service to their clients and ultimately to patients,” João Malagueira, VP of diagnostics for Hologic’s EMEA unit, said in prepared remarks.

“With rising antibiotic resistance in Europe and the threat posed by healthcare-associated infections to public health, our new assay will help customers provide a rapid service to hospitals, so cases of resistance, such as MRSA, are identified and managed quickly and effectively,” Malagueira added.

HOLX shares were trading at $39.72 apiece in mid-morning activity today, up 0.5%.

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7 medtech stories we missed this week: May 25, 2018

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From Mauna Kea receiving FDA clearance to Medacta getting clearance for its pedicle screw placement guide, here are seven medtech stories we missed this week but thought were still worth mentioning.

1. Mauna Kea wins FDA nod for neurosurgery indication

Mauna Kea announced in a May 24 press release that it has received FDA 510(k) clearance for its Celivizio 100 series F400 and F800 with new Confocal Miniprobe, the CranioFlex. The clearance allows the device to be used during neurosurgical procedures. The Cellvizio 100 with CranioFlex gives allows for imaging of tissue internal microstructures and allows for identification of cells and vessels and their organization in the central nervous system during cranial diagnostic and therapeutic procedures. The F400 series operates at 488 nm and the F800 model operates at 800 nm.

2. Bonesupport, Collagen Matrix ink deal

Bonesupport has signed a strategic agreement with Collagen Matrix to expand its product offering to the U.S., according to a May 24 press release. The agreement states that Bonesupport will start selling and marketing some of the Collagen Matrix bone graft substitute products under its own brand and through its own distribution network in the fourth quarter of this year.

3. Implanet launches Jazz Evo spine implant

Implanet announced in a May 23 press release that it has launched its Jazz Evo implant that is designed to respond to the constraints of vertebral fusion indications in adults. The implant is designed to facilitate the treatment of degenerative pathologies in adults and is part of the company’s Jazz range of products that block the braid with a single screw to ensure optimum clamping on the rod without damaging the braid.

4. MC10 wins FDA nod for BioStamp nPoint wireless patient monitor

MC10 recently received FDA 510(k) clearance for its BioStamp nPoint System, according to a May 16 press release. The system is a wireless, biometric data collection platform that is designed to be used by healthcare professionals and researchers for collecting physiological data continuously in the home or in traditional healthcare settings. It is specifically designed for clinical trials or research studies where continuous collective data is needed. It features flexible, body-conforming rechargeable sensor patches that are reusable and can record data for up to 24 hours. It can be configured to measure, record and display general activity, postural classifications, vital signs and sleep metric with clinical validated accuracy.

5. FDA clears second XableCath peripheral catheter

XableCath announced in a May 24 press release that it has received FDA clearance for its XableCath abrasion tip support catheter. This clearance marks the second clearance for the company after its blunt tip catheter was cleared at the end of 2017. Both XableCath’s designs are designed to easily slide past occluding atheroma through the true lumen of the vessel.

6. CrossRoads Extremity Systems launches DynaForce foot implant

CrossRoads Extremity Systems has launched its Active Stabilization MPJ Implant System, according to a May 22 press release. The company launched the product after it received FDA clearance for its DynaForce system. The DynaForce Active Stabilization MPJ Implant System combines stability and an anatomic plate with active compression of a nitinol clip that is delivered to the operating room in a sterile package.

7. FDA clears Medacta pedicle screw guide

Medacta announced in a May 23 press release that it has received FDA clearance for its MySpine Midline Cortical Pedicle Screw Placement Guide. The MySpine MC system allows surgeons to optimize procedures for both outpatient and inpatient settings for a more rapid patient recovery through accurate and reliable muscle-sparing approaches to posterior lumbar surgery. The system guides the screw to a trajectory in the pedicle that has evolved from a cortical bone trajectory. The system also avoids interference with cranial facet joins and can accommodate larger screw diameters and lengths with four points of cortical bone purchase.

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PavMed subsidiary Lucid Dx inks licensing deal with Case Western Univ.

Pavmed (NSDQ:PAVM) subsidiary Lucid Diagnostics said today it finalized a licensing agreement with Case Western Reserve University to commercialize its EsoCheck non-invasive cell sampling device and DNA biomarker test.

The New York-based company said that the EsoCheck device has been shown to effectively and accurately detect Barrett’s Esophagus, which is a precursor to the most common and lethal forms of esophageal cancer caused by Gastroesophageal Reflux Disease.

The EsoCheck test is composed of a pill-sized capsule with a small inflatable balloon attached to a thin catheter. The patient swallows the capsule, which swabs the target area for a sample of cells as it is withdrawn, the company said.

Collected samples are then tested for biomarkers that have been shown to be accurate for detecting Barrett’s Esophagus.

As part of the licensing agreement, PavMed’s Lucid Diagnostics will own the exclusive worldwide right to develop both the device and biomarker test and the associated intellectual property.

“EsoCheck is a revolutionary technology that we believe will save many lives through the early detection of pre-cancerous conditions of the esophagus including Barrett’s Esophagus. We are proud to have been selected to be the exclusive commercial partner of Case Western Reserve University in this important endeavor. Based on the dramatic results of the recently published multicenter clinical study, we believe widespread EsoCheck screening has the potential to have as great an impact on esophageal cancer as widespread Pap screening has had in preventing cervical cancer, targeting an estimated immediately addressable domestic market of several billion dollars,” PavMed chair & CEO Dr. Lishan Aklog said in a press release.

PavMed said that it has launched a multicenter National Institutes of Health study of the EsoCheck, and that it is enrolling patients at Case Western Reserve University Hospital and other healthcare facilities.

“Our multicenter NIH study aims to establish the clinical evidence for EsoCheck’s widespread use as a screening test to detect Barrett’s Esophagus, eventually targeting the estimated 50 million Americans with and without heartburn who are at risk. The EsoCheck device is already being manufactured for human use in clinical trials and the EsoCheck DNA biomarker test is already being performed at a reference laboratory, which expects to receive CLIA certification later this year. As such, we will be able to aggressively pursue EsoCheck commercialization by seeking U.S. Food and Drug Administration (FDA) 510(k) clearance of the cell sampling device and a Laboratory Developed Test designation of the DNA biomarker test. We are targeting the first quarter of 2019 for the launch of the first commercial product in the U.S.,” principal investigator and EsoCheck co-inventor Dr. Amitabh Chak of the Case Western University School of Medicine said in a prepared statement.

Earlier this month, PavMed said that it filed a preliminary prospectus with the SEC for an offering of the rights to buy a new unit in exchange for each share of outstanding common stock.

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Siemens Healthineers and Hill-Rom team up to provide diabetes tools to primary care providers

Siemens Healthineers (NYSE:SI) and Hill-Rom (NYSE:HRC) inked a co-marketing agreement to provide an array of point-of-care diagnostic instruments for diabetes to primary healthcare providers in the U.S.

The offering is slated to include Siemens’ DCA Vantage Analyzer for HbA1c testing, the Clinitek Status+ Urine Chemistry Analyzer for kidney testing and Hill-Rom’s Welch Allyn RetinaVue Network and imaging tech for teleretinal exams.

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

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Quest Diagnostics posts mixed Q1

Shares in Quest Diagnostics (NYSE:DGX) held steady today after the company met earnings expectations on Wall Street but missed analysts’ sales estimates with its first-quarter results.

The Secaucus, N.J.-based company posted profits of $177 million, or $1.27 per share, on sales of $1.88 million for the 3 months ended March 31, for bottom-line growth of 7.9% on sales growth of 3.7% compared with the same period last year.

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

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